prEN ISO 22523

prEN ISO 22523: External limb prostheses and external orthoses - Requirements and test methods (ISO/DIS 22523:2026)

ISO/DIS 22523.2:2026(en)

ISO/TC 168

Date: 2023-02-10

Secretariat: DIN

External limb prostheses and external orthoses — Requirements and test methods

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Contents

Foreword xi

1 Scope 1

2 Normative references 1

3 Terms and definitions 1

4 General requirements 2

4.1 Risk management 2

4.2 Intended performance and technical documentation 3

4.3 Clinical evaluation 3

4.4 Strength and related conditions of use 3

5 Requirements for materials 5

5.1 Flammability of materials and toxicity of combustion products 5

5.2 Biocompatibility, contaminants and residues 5

5.2.1 General 5

5.2.2 Contaminants and residues 5

5.3 Infection and microbial contamination 5

5.4 Resistance to corrosion and degradation 6

6 Noise and vibration 6

7 Electromagnetic compatibility (EMC) 6

8 Electrical safety 7

8.1 Battery-powered prosthetic and orthotic devices 7

8.1.1 Battery housings and connections 7

8.1.2 Charge level indicators 7

8.2 Circuit protection 7

8.3 Electronic programmable systems 7

8.4 Electrically heated blankets, pads and similar flexible heating appliances 7

8.5 Prosthetic and orthotic devices with skin contact electrodes 7

8.6 Prosthetic and orthotic devices with radio equipment 7

8.6.1 General 7

8.6.2 Frequency spectrum of radio equipment 8

8.6.3 Operation of radio equipment by the user 8

9 Surface temperature 8

10 Design requirements 8

10.1 Safety of moving parts 8

10.2 Safety of connections 8

11 Mechanical requirements 9

11.1 Restrictions on use 9

11.2 Forces in soft tissues of the human body 9

11.3 Ergonomic principles 9

12 Information supplied by the manufacturer 10

Annex A (informative) Guidance on methods of determining the strength of upper-limb prosthetic devices 11

A.3.2 Selection of test samples 11

A.3.3 Preparation of test samples 12

A.3.4 Alignment of test samples 16

A.3.5 Orientation marks on test samples 17

A.4 Number of tests and test samples required 17

A.5 Multiple use of test samples 17

A.5.1 General 17

A.5.2 Restriction 18

A.6 Conformity of any test sample with the requirements of the cyclic tests of this annex cannot be claimed if the test sample has previously been subjected to any of the static tests of this annex at a load level required to determine the ultimate strength [see 4.4.4 a) 3)].Test submission document 18

A.6.1 General requirements 18

A.6.2 Information required for test samples 18

A.6.3 Information required for tests 18

A.7 Accuracy 19

A.7.1 General 19

A.7.2 Accuracy of equipment 19

A.7.3 Accuracy of procedure 19

A.8 Static tests 19

A.8.1 General 19

A.8.2 Distal tensile test (Test 1) 20

A.8.3 Static downward bending test (Test 2) 20

A.8.4 Static upward bending test (Test 3) 21

A.9 Cyclic tests 22

A.9.1 General 22

A.9.2 Cyclic downward bending test (Test 4) 22

A.9.3 Cyclic upward bending test (Test 5) 23

A.10 Test report 24

A.10.1 General requirements 24

A.10.2 Specific requirements 24

A.10.3 Options 24

Annex B (informative) Guidance on methods of determining the mechanical properties of knee joint assemblies for lower-limb orthotic devices 25

Annex C (informative) Guidance on methods of determining the flammability and toxicity of combustion products of lower-limb prosthetic devices 26

C.1 General 26

C.2 Principle 26

C.3 Test submission document 26

C.4 Safety requirements 26

C.5 Test samples 27

C.5.1 Sample, nature and source 27

C.5.2 Sample identification 27

C.5.3 Sample dimensions 27

C.5.4 Sample conditioning 27

C.6 Test arrangements 27

C.6.1 Test room 27

C.6.2 Sample support frame 28

C.6.3 Apparatus 28

C.6.3.1 Radiant heat source 28

C.6.3.2 Flame ignition source 29

C.6.3.3 Weighing platform 29

C.6.3.4 Video/photographic recording 29

C.7 Test procedures 29

C.7.1 General 29

C.7.2 Radiant heat source 30

C.7.3 Flaming ignition source 30

C.8 Determination of the “Total Toxic Potential Dose” (TTPD) 31

C.8.1 Rationale for the toxicity criterion based on mass loss 31

C.8.2 Calculation of the “Total Toxic Potential Dose” (TTPD) 31

C.9 Pass/fail criteria 32

C.9.1 Radiant heat source test 32

C.9.2 Flaming ignition source test 32

C.10 Test report 32

Annex D (informative) Guidance on methods of establishing the force or moment required to operate the control and actuating mechanisms on prosthetic and orthotic devices 40

D.1 General 40

D.2 Principle 40

D.3 Test samples 41

D.3.1 Categories of test sample 41

D.3.2 Preparation of test samples 41

D.4 Number of required tests 43

D.5 Accuracy 43

D.6 Methods of testing 43

D.6.1 General 43

D.6.2 Test set-up for sample category: Orthotic knee joints with locking mechanism 44

D.6.3 Test set-up for sample category: Orthotic elbow joints with locking mechanism 45

D.6.4 Test set-up for sample category: Prosthetic knee units with locking mechanism 46

D.6.5 Test set-up for sample category: Prosthetic elbow units with locking mechanism 47

D.6.6 Test set-up for sample category: Prosthetic elbow units with user-driven articulation 48

D.6.7 Test set-up for sample category: Prosthetic terminal devices with built-in closing function 48

D.6.8 Test set-up for sample category: Prosthetic terminal devices with built-in opening function 49

D.6.9 Test set-up for sample category: Prosthetic terminal devices with no built-in closing or opening function, actuated by force application 49

D.6.10 Test set-up for sample category: Prosthetic terminal devices with no built-in closing or opening support, actuated by torque application (rotation of the forearm relative to the socket) 50

D.6.11 Test set-up for sample category: Prosthetic terminal devices with break-open feature for emergency situations 50

D.6.12 Test set-up for sample category: Prosthetic devices with fail-safe release units 51

D.7 Test report 51

D.7.1 General 51

D.7.2 Specific requirements 51

D.8 Test results 52

Annex E (informative) Reference to the essential principles of safety and performance of medical devices in accordance with ISO/TR 16142 64

Annex F Symbols specifying the environmental conditions that prosthetic or orthotic components can withstand 66

Annex ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered 68

Bibliography 71

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 168, Prosthetics and orthotics.

This second edition cancels and replaces the first edition (ISO 22523:2006), which has been technically revised.

The main changes are as follows:

— in 4.2, the technical documentation has been revised;

— update of 5.2.1 on biocompatibility;

— the content of former Annex B has been removed.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

External limb prostheses and external orthoses — Requirements and test methods

1.0 Scope

This document specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:

06 03 to 06 15 Orthoses

06 18 to 06 24 Limb prostheses

This document covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components. This document is also applicable as guidance in the design and test of custom build orthosis and prosthesis.

NOTE The use of quality systems as described or referred to in ISO 13485 and ISO 13488 can be appropriate.

2.0 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 10328, Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

ISO 15032, Prostheses — Structural testing of hip units

ISO 20417, Medical devices — Information to be provided by the manufacturer

ISO 22675, Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods

IEC 60601‑1, Medical electrical equipment — Part 1: General requirements for safety

IEC 60601‑1-2, Medical electrical equipment — Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests

3.0 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 8548, ISO 8549, ISO 13404, ISO 13405 and the following apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp

— IEC Electropedia: available at https://www.electropedia.org/

3.1

prosthetic device

external limb prosthesis

externally applied device consisting of a single component or an assembly of components used to replace wholly, or in part, an absent or deficient lower or upper-limb segment

3.2

orthotic device

external orthosis

externally applied device consisting of a single component or an assembly of components applied to the whole or part of the lower limb, upper-limb, trunk, head or neck and their intermediate joints to assist the neuro-muscular and skeletal systems

3.3

user

person using (wearing) the prosthetic or orthotic device

3.4

attendant

person who assists the user

3.5

technical documentation

manufacturer's record of data showing conformity of a prosthetic or orthotic device intended to be used as part of the technical documentation required by the Medical Devices Directive for conformity assessment procedures

3.6

clinical evaluation

a set of ongoing activities that use scientifically sound methods for the assessment and analysis of clinical data to verify the safety, clinical performance and/or effectiveness of the device when use as intended by the manufacturer

[SOURCE: IMDRF MDCE WG/N56FINAL:2019]

3.7

clinical investigation

systematic investigation in one or more human subjects, undertaken to assess the clinical performance, effectiveness or safety of a medical device

[SOURCE: ISO 14155:2020, 3.8, modified – Note 1 to entry has been removed.]

3.8

radio equipment

product or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilizing the spectrum allocated to terrestrial/space radio communication

3.9

leg dummy

part of the test setup, which mimics the orthosis users leg

4.0 General requirements

4.1 Risk management

Possible hazards associated with a prosthetic or an orthotic device can endanger the user. For this reason, the manufacturer shall establish and maintain a process for identifying those hazards and evaluating the associated risks, controlling these risks and monitoring the effectiveness of the control. This risk management process shall include the following elements:

risk analysis;

risk evaluation;

risk control;

post-production information.

NOTE 1 ISO 14971 can be used as guidance.

NOTE 2 Using ISO 14971, as guidance, does not require that the manufacturer has a formal quality system in place. However, risk management can be an integral part of a quality system.

The results of the risk management process may be used to select from this document the requirements which apply.

4.1.1 Intended performance and technical documentation

The intended performance including, where appropriate, strength and durability of a prosthetic or orthotic device shall be described in the technical documentation which sets out its functional characteristics, its application(s) and conditions of use.

The technical documentation shall include, where appropriate, references to relevant clinical and scientific literature, any strength and/or life calculations, appropriate standards and test results.

The technical documentation shall specifically include a statement about the life time of the device. The number of test cycles a device underwent, e. g. when tested in accordance with ISO 10328 or ISO 22675, can be a useful indicator when determining the life time of the device.

4.1.2 Clinical evaluation

Any clinical investigation shall be performed in accordance with ISO 14155.

The judgement of CPO (certified prosthetist and orthotist) and biomechanical engineers is particularly relevant and should be taken into account when clinically evaluating prostheses and orthoses.

There is insufficient data on a significant portion of prosthesis and orthosis which has been placed on the market during past decades. Post market analysis of data by manufacture and organisation are the source of continuous improvement and continuous development.

4.1.3 Strength and related conditions of use

4.4.1 A prosthetic or orthotic device shall have the strength to sustain the loads occurring during use by amputees, or other persons with a physical handicap, in the manner intended by the manufacturer for that device according to the written instructions on its intended use.

NOTE For further information see 5.4 and NOTE in 5.2.2.

4.4.2 In order to conform with the requirement(s) of 4.4.1, the relevant requirements of 4.4.3 to 4.4.7 shall be met.

4.4.3 The strength of a lower-limb prosthetic device shall be determined by application of the relevant tests specified in ISO 10328, ISO 22675 and/or ISO 15032 at a specific test loading level.

NOTE 1 ISO 10328 does not include test methods for flexion testing of knee units with stance phase control mechanisms.

4.4.4 The strength of all other prosthetic and orthotic devices shall be determined in the manner specified in a) to d).

The justification for the manufacturer's selections in a) to d) shall be recorded in the technical documentation (see 4.2).

a) The manufacturer shall specify which of the following category/categories of strength is/are considered to be appropriate:

1) fatigue strength: the cyclic load which can be sustained for a prescribed number of cycles;

2) proof strength: the static load representing an occasional severe event, which can be sustained and still allow the prosthetic or orthotic device to function as intended;

3) ultimate strength: the static load representing a gross single event, which can be sustained but which might render the prosthetic or orthotic device thereafter unusable.

b) The manufacturer shall specify the strength level(s) considered to be appropriate.

c) The manufacturer shall specify the method(s) of test to be applied, with the exception described in 4.4.5.

NOTE 1 An upper-limb prosthetic device can be tested, if appropriate, using the methods specified in Annex A.

NOTE 2 An orthotic device can be tested, if appropriare, using the methods specified in Annex B.

d) The manufacturer shall specify the test loading condition(s) and/or the test loading level(s) at which the test(s) shall be conducted. The specified loading condition(s) shall include the worst case situation in relation to clinical indication and patient characteristics (remaining muscle strength, deformities and contractures, spasticity, bodyweight, etc.).

4.4.5 An orthotic assembly for the lower limb shall be tested in a validated test setup, which includes a leg dummy to load the orthotic assembly as specified in 4.4.1. Functional properties of orthotic devices, claimed by manufacturers / submitters, shall be quantified prior and after the cyclic test and both shall be documented in the technical documentation.

NOTE Experience shows, that using a leg dummy which does not stabilize the orthotic assembly beyond the stabilization the users leg applies, and footwear where appropriate, and testing the strength category/categories in a static- or durability in a rollover scenario, are appropriate measures to apply the required complex loadings to orthotic assemblies. The amount of loads applied during testing can be obtained or validated through measurements using instrumented orthotic components (joints, bars etc.).

4.4.6 Details of the category/categories of strength and strength level(s) specified and details of the tests, test loading conditions and/or test loading levels applied to the prosthetic or orthotic device shall be given in the information supplied by the manufacturer (see Clause 13).

4.4.7 The manufacturer shall specify the loading conditions for a prosthetic or orthotic device to conform with the requirements of 4.4.1. Reference shall be made to loading parameters and/or other conditions of the intended use that can be quantified or that are known to be interpreted in a uniform way.

NOTE For lower-limb prosthetic devices, the body mass is the quantifiable loading parameter commonly referred to.

The specification of these loading parameters and/or other relevant conditions of use shall take account of the safety factors corresponding to the particular use of the prosthetic or orthotic device intended by the manufacturer, which are determined by the ratio between the test loading conditions and/or test loading levels applied to the device and the corresponding loads expected to be exerted on the device during use by amputees or other persons with a physical handicap in the manner intended by the manufacturer.

4.4.8 Details of the loading conditions for a prosthetic or orthotic device, specified by the manufacturer in accordance with 4.4.7, shall be stated in the information supplied by the manufacturer with the device (see Clause 13).

4.4.9 Details of the specific loading parameters and/or other relevant conditions of use according to 4.4.7, required to conform with the requirements of 4.4.1 for a prosthetic or orthotic device, shall be stated in the written instructions on the intended use of that device, supplied by the manufacturer with the device (see Clause 13).

5.0 Requirements for materials

5.1 Flammability of materials and toxicity of combustion products

5.1.1 In prosthetic or orthotic devices, every effort shall be made to use materials which minimize the risk of propagation of flames, as it is of particular importance to disabled persons who might not be able to escape from a fire. The use of non-flame-retardant materials shall be regularly reviewed as there is continuous development in this field.

NOTE To test materials used in lower-limb prosthetic devices, the test methods specified in ISO 8191-1 or UL94 or Annex C can be used. The appropriate level for testing can be determined by the manufacturer.

IEC 60601-1 shall apply for medical electrical equipment. Only parts with a volume of more than 500 mm³ shall be evaluated as a potential risk. The manufacturer shall evaluate any risk resulting from the fume.

5.1.1 Biocompatibility, contaminants and residues

5.1.2 General

Materials that come into contact with the human body shall be assessed for biocompatibility, taking into account the intended use and contact by those involved in user care or transportation and storage of the product.

NOTE 1 Guidance for biological evaluation and selection of appropriate tests is given in ISO 10993-1.

NOTE 2 For some materials assessments, using Standard 100 by OEKO-TEX® or the REACH Regulation can be useful in ascertaining that no hazardous substances are included in them, which in turn can be helpful when carrying out the biological evaluation.

5.1.3 Contaminants and residues

The risk of substances leaking from the device shall be assessed.

NOTE 1 ISO 14971 provides one approach for a risk management which might be useful.

NOTE 2 Substance that can leak include lubricants, hydraulic fluids and battery fluids.

5.2 Infection and microbial contamination

The manufacturer shall specify the method and frequency by which a prosthetic or orthotic device and/or the body surface to which it applies can be cleaned.

EXAMPLE Usually, devices are cleaned by the CPO or the patient with mild soap and clear water with a soft tissue.

The risk of infection or microbial contamination shall be evaluated.

NOTE ISO 14971 provides one approach for a risk management which might be useful.

Animal tissue products can carry infection and microbiological contamination, and manufacturers should examine them for signs of disease or contamination. For more information see ISO 22442-1.

5.2.1 Resistance to corrosion and degradation

If the strength of a prosthetic or orthotic device, or the safety of the user or an attendant, can be affected by corrosion and/or degradation, risk analysis shall be used to determine the most appropriate protective measures.

For any corrosion test, the risk of combined stress and corrosion should be considered.

Annex F provides a list of symbols to describe the environmental conditions that prosthetic or orthotic components can withstand. For prosthetic components, the symbols shall be included in instructions for use, and they should be included in catalogues, brochures, marketing materials, and other product advertisements. For orthotic components, the use of the symbols is suggested. Symbols are not required on the component or component data label.

NOTE ISO 9227, ASTM G85 or ASTM B117 might be used for the assessment of corrosion resistance of metallic materials.

6.0 Noise and vibration

There are no specific requirements for prosthetic and orthotic devices except for medical electrical equipment

NOTE IEC 60601-1 can IEC 60601-11 be used for a guidance for medical electrical equipment.

7.0 Electromagnetic compatibility (EMC)

Where relevant, a prosthetic or orthotic device shall satisfy the EMC requirements by conforming with IEC 60601-1-2.

Manufacturers should consider the electromagnetic environments in which their products are likely to be used and the possible consequences of malfunction.

Where relevant, prosthetic and orthotic devices may be used in the presence of other electronic equipment. The electromagnetic compatibility (EMC) should be carefully matched to the environment in which the device is intended to be used.

When specifying the EMC performance of the device, manufacturers should recognize the already widely accepted environments of

— residential, commercial and light industrial;

— industrial;

— other (typically meaning more harsh environments and some specific places such as hospitals or near specific machinery, e.g. transmitters and security scanners in public and other places).

8.0 Electrical safety

8.1 Battery-powered prosthetic and orthotic devices

8.1.1 Battery housings and connections

Battery housings and connections incorporated in a prosthetic or orthotic device shall conform with the requirements of IEC 60601-1.

NOTE IEC 60601-1 and IEC 60601-1-11 can be used as guidance.

8.1.2 Charge level indicators

If the safety of the user depends upon the internal power supply of a prosthetic or orthotic device, that device shall be equipped with a means of indicating the state of the power supply prior to the critical state which results in an unacceptable risk.

NOTE IEC 60601-1 can be used as a guidance.

8.2 Circuit protection

If the power supply of a prosthetic or orthotic device can be overloaded in use and the overload can cause a risk to the user, that device shall be protected against the overload.

NOTE IEC 60601-1 can be used as a guidance.

8.2.1 Electronic programmable systems

A prosthetic or orthotic device incorporating electronic programmable systems shall be designed to ensure the repeatability, reliability and performance of the systems according to their intended use.

Any software which can be used to control an electronic programmable system shall be designed to ensure its repeatability, reliability and performance according to its intended use.

NOTE IEC 60601-1,, IEC 62304 and IEC 62366 can be used as a guidance.

8.2.2 Electrically heated blankets, pads and similar flexible heating appliances

A prosthetic or orthotic device that incorporates flexible heating appliances should conform to the requirements of IEC 80601-2-35.

8.2.3 Prosthetic and orthotic devices with skin contact electrodes

The manufacturer shall conduct a risk analysis to assess the safety risks related to the use of skin contact electrodes incorporated in a prosthetic or orthotic device used for nerve and muscle stimulation.

NOTE IEC 60601-1 can be used as guidance.

8.2.4 Prosthetic and orthotic devices with radio equipment

8.2.5 General

Radio equipment incorporated in and/or used together with a prosthetic or orthotic device shall conform with the relevant requirements of IEC 60601-1.

8.2.6 Frequency spectrum of radio equipment

Radio equipment incorporated in and/or used together with a prosthetic or orthotic device shall be so constructed that the frequency spectrum used does not cause harmful interference, i.e. interference which endangers the functioning of radio navigation service or of other safety services or which otherwise seriously degrades, obstructs or repeatedly interrupts a radio communications service operating.

8.2.7 Operation of radio equipment by the user

The manufacturer shall assess the particular conditions of operation of radio equipment incorporated in and/or used together with a prosthetic or orthotic device with respect to the capabilities of the intended user and regard the results in his decision on the appropriate design of control units or elements.

9.0 Surface temperature

A prosthetic or orthotic device may contain units which absorb energy and therefore rise in temperature during normal intended use resulting in the risk of injury to the user touching the device.

The possibility of a temperature rise which may impair comfort should be investigated.

Wherever possible, a device such as that referred to in the first paragraph shall be provided with a means of protection to remove or minimize the risk.

If means of protection cannot be incorporated in such a device, clear warnings shall be given either on the device or with the instructions for use (see Clause 12).

NOTE IEC 60601-1 can be used as a guidance.

10.0 Design requirements

10.1 Safety of moving parts

NOTE 1 Due to the nature of its intended purpose, some parts of a prosthetic or orthotic device can be required to move relative to each other and as a result can trap and damage parts of the body or clothing of users or other persons.

Wherever possible such a device shall be provided with means of protection to remove or minimize the risk during normal intended use.

NOTE 2 ISO 14971 provides one approach for a risk management which might be useful.

Wherever possible such a device shall be provided a cover to avoid entrapment for human fingers.

If a means of protection cannot be incorporated in such a device, clear warnings shall be given either on the device or with the instructions for use (see Clause 13).

NOTE 3 Annex E gives guidance on reference to the essential principles of safety and performance of medical devices in accordance with ISO/TR 16142.

10.1.1 Safety of connections

The terminals and connectors to the electric and/or fluid energy supplies or other connections of a prosthetic or orthotic device which the user requires to handle shall be designed and constructed in such a way as to minimize risk to the user. The reliability of the connector during the life of the product should be considered.

NOTE IEC 60601-1 can be used as a guidance.

11.0 Mechanical requirements

11.1 Restrictions on use

If a prosthetic or orthotic device can be produced by combining components or assemblies of components from different manufacturers, the combination shall satisfy the requirements in 11.1.2.

The manufacturer of a component and/or assembly of components shall provide information on the other components which are known to be suitable for use in combination (see Clause 12).

The manufacturer of a component and/or assembly of components shall provide information on any limitation on the use of a prosthetic or orthotic device to any specific parameter such as loading (see Clause 12).

The risk of incompatibility between components used in the device shall be evaluated.

NOTE 1 ISO 14971 provides one approach for a risk management which might be useful.

NOTE 2 ISO 24562 provides guidance on the choice of geometrical aspects of pyramidal adapters.

11.1.1 Forces in soft tissues of the human body

Prosthetic and orthotic devices by the nature of their functions require to apply forces to the body segments to which they are attached. The interface components of devices should be designed to avoid unacceptable pressure on and stress levels in body tissues.

Mechanically based risks to tissue can include the following:

— cell necrosis due to restricted nutrition and oxygen supply;

— tissue breakdown due to mechanical overload;

— tissue breakdown due to fatigue;

— tissue wear due to abrasion;

— cell destruction due to thermal coagulation.

11.1.2 Ergonomic principles

If the operation of a prosthetic or orthotic device requires the user to apply a force or moment to an actuator, the manufacturer shall ensure that the magnitude of the required force or moment is suitable for the user.

Prosthetic and orthotic devices should be designed on ergonomic principles taking into account the special needs of the intended user. If a device or one of its components or assemblies of components requires adjustment or operation by the user, the means of adjustment or operation should be easily accessible and ergonomically practicable for the user.

NOTE 1 Annex D describes methods of establishing the force or moment required to operate the control and actuating mechanisms on prosthetic and orthotic devices and can be used as guidance.

It has been found in practice that the minimum value of the operating force or moment to be applied by the user to the actuator of the control or actuating mechanism of a complete prosthetic or orthotic device should be at least 5 N or 0,1 N^.m in order to avoid accidental operation of that control or actuating mechanism.

NOTE 2 For further information on ranges of operating force or moment measured on samples of orthotic knee and elbow joints, prosthetic knee and elbow units and prosthetic terminal devices, see Clause D.6.

12.0 Information supplied by the manufacturer

12.1 General

12.1.1 The information supplied with a prosthetic or orthotic device shall conform to the requirements of ISO 20417.

12.1.2 The information supplied with a prosthetic or orthotic device shall include those of the items addressed or specified in 4.4.6, 4.4.8, 4.4.9, 5.1.2, 5.3, Clause 9, 10.1 and 11.1, which are relevant to that device.

If appropriate, the user should be advised that the safety and lifetime of the prosthetic or orthotic device depends upon the level of his/her activity while using the device (see 4.2).

12.1.3 If a prosthetic or orthotic device uses visual, audible or other sensible (sensory) signals to indicate operating or adjusting parameters, the manufacturer shall ensure that the meaning of these signals is understandable to the user and other involved persons.

NOTE IEC 62366-1 and ISO 14971 can be used as a guidance.

12.1.1 Labelling

Labelling shall follow the requirements of ISO 20417.

12.1.2 Intended use

12.3.1 The written instructions on the intended use of a prosthetic or orthotic device, supplied by the manufacturer with the device, shall comprise at least

a) specification of prosthetic or orthotic body location,

b) for prosthesis, specification of the permissible maximum values of principal loading parameters or permissible threshold values of other relevant conditions of use, which limit the loads allowed to be exerted on the prosthetic device during use by amputees or other persons with a physical handicap, who are intended to be fitted with this device (see 4.4.7, 4.4.8 and 4.4.9), and

c) statement of the assemblies and/or alignments in which the prosthetic or orthotic device can be used (see 12.1).

12.3.2 If specific requirements for the instructions on the intended use are included in the relevant standard(s) and/or specification(s) listed in 4.4.3 and addressed in 4.4.4 and 4.4.5, these shall apply.

13.0 Packaging

Manufacturers should address the need for protective packaging.

The packaging of a prosthetic or orthotic device is intended to provide appropriate protection against damage, deterioration or contamination during storage and transportation to the point of use. The various forms of storage and the types of transportation that might be encountered therefore should be considered, and the effectiveness of the packaging checked.

(informative)

Guidance on methods of determining the strength of upper-limb prosthetic devices
1. General

The evaluation of upper-limb prosthetic devices described in this annex concentrates on structural strength. The test instructions specify which properties are to be tested and measured and the manner in which tests are to be carried out.

NOTE Either complete prostheses or sub-assemblies or single components can be tested.

This annex does not cover associated requirements for field trials, wear, environmental and functional tests.

This annex does not cover cosmetic devices.

The laboratory tests and field trials shall be repeated when significant design changes are made to load-bearing parts of an upper-limb prosthetic device.

1. Principle

The method of evaluating the strength of upper-limb prosthetic devices is based on a series of laboratory tests consisting of a static tensile test, and static and cyclic downward and upward bending tests.

The static tensile test is intended to be applied to test samples of upper-limb prosthetic devices of any composition, aligned in full extension.

The static and cyclic downward and upward bending tests are intended to be applied to test samples of upper-limb prosthetic devices, incorporating an elbow and/or shoulder unit with a locking mechanism or other means of maintaining the angle of flexion/extension and adduction/abduction which allow(s) their alignment as close as possible to the following situation (see also A.3.4):

— shoulder unit in neutral position of flexion/extension and adduction/abduction;

— elbow unit in flexed position with forearm at right angles to the upper arm.

1. Test samples
  1. General

The manufacturer/submitter shall prepare a test sample description in accordance with ISO 13405-3, to be submitted together with the test submission document (see clause A.6).

- 1. Selection of test samples

The test samples of upper-limb prosthetic devices selected for test shall be taken from normal production. Details of the selection shall be recorded in the test submission document. If the manufacturer/submitter supplies a certificate stating that the test sample has been taken from the normal production, this certificate shall be included in the test submission document, together with details of the sampling method.

NOTE Test samples of prosthetic structures can also be submitted for specific tests by any interested party.

- 1. Preparation of test samples

All sub-assemblies and single components submitted for test shall have the manufacturer's/submitter's recommended wrist longitudinal axis of rotation, elbow axis of rotation, elbow midpoint on the axis of rotation (centre of the elbow unit), upper arm (humeral) longitudinal axis, shoulder axis of rotation, and shoulder midpoint on the axis of rotation (centre of shoulder unit), in order to allow their correct positioning in the test sample set-up as specified in this subclause and in A.3.4. If the shoulder is a spherical joint, the shoulder axis of rotation is undefined and the midpoint on the axis of rotation coincides with the geometrical centre of the spherical joint.

Omit cosmetic fairings from the sample unless they contribute to the structural strength, or are subject of a requirement of a specific test.

Ensure that the test sample is provided with an upper (proximal) end attachment, required for the fixation of the test sample within the test equipment, and with a lower (distal) end attachment or a special grip device for a terminal device (see below), required for the application of the distal test force to the test sample.

Prepare the location of the point of load application P of the distal test force to the test sample as follows.

a) If the test force is to be applied to a distal end attachment, point P shall be located on the long axis of the lower arm at a distance, c, from the elbow centre (see Figure A.1.)

b) If the test force is to be applied to the special grip device described, point P shall be located as specified in 1) and 2):

1) For the distal tensile test (see A.8.2), point P should be the connecting point of the attachment cable/cord of the grip device, as illustrated in Figure A.2.

2) For the static and cyclic downward and upward bending tests (see A.8.3, A.8.4, A.9.2 and A.9.3), point P shall be the centre of the outer surface of the circular plate of the grip device on the side of load application, as illustrated in Figures A.3 and A.4.

Ensure that the end attachments, as far as possible, match the physical characteristics of the adjacent components used in the prosthetic device so that representative loads are applied.

NOTE This can be achieved by use of the intended adjacent components with the sample for test (see Figure A.5).

Representative loads may also be applied by the special grip devices, addressed in the above and specified below.

Unless otherwise specified by the test laboratory/facility, the preferred grip device for a terminal device shall be a rod of 19 mm diameter, 100 mm length and a surface roughness Ra of 1,6 μm.

For the distal tensile test specified in A.8.2 the rod shall be configured as illustrated in Figure A.2.

For the bending tests specified in A.8.3, A.8.4, A.9.2 and A.9.3, circular plates of 70 mm diameter and 5 mm thickness should be placed at each end of the cylinder, one of the plates providing means of load application.

If appropriate, a socket may be used and may be partially filled to provide an upper (proximal) end attachment. Ensure that the distal 15 mm (minimum) of the internal length of the socket is maintained void or filled with soft cushioning material.

The representative test sample segment lengths, c and d, are specified in the table in Figure A.1, together with further dimensions for orientation.

Key

1	shoulder joint axis of rotation
2	elbow joint axis of rotation
F	distal test force
P	load application point
a	distance from the elbow axis of rotation to the distal end of the wrist joint
b	distance of the hand or distal end attachment from the wrist joint distal end to the force application point
c	distance from the elbow axis of rotation to the midpoint of the hand grip position or test force application point on distal end attachment
d	distance from the shoulder axis of rotation to the elbow axis of rotation
e	distance of the wrist joint included in a)
f	distance from the proximal plane of the elbow unit to the elbow axis of rotation

Segment length	Dimension mm		Comments
Segment length	Child	Adult	Comments
a	(≈150)	(≈250)	For orientation only
b	(≈60)	(≈100)	For orientation only
c = a + b	210	350	Representative
d	150	250	Representative
e	—	—	Dependent on individual design
f	—	—	Dependent on individual design

Figure A.1 — Test sample segment distances

Key

F test force

P load application point

Figure A.2 — Configuration of test 1

Key

1 shoulder joint axis of rotation

2 elbow joint axis of rotation

3 axis of the test force, parallel of the test force and the axis between 1 and 2

F test force

P load application point

c distance from the elbow axis of rotation to the midpoint of the hand grip position or test force application point on distal end attachment

d distance from the shoulder axis of rotation to the elbow axis of rotation

Figure A.3 — Configuration of test 2 and test 4

Key

1 shoulder joint axis of rotation

2 elbow joint axis of rotation

3 axis of the grip device, parallel of the test force

F test force

P load application point

c distance from the elbow axis of rotation to the midpoint of the hand grip position or test force application point on distal end attachment

d distance from the shoulder axis of rotation to the elbow axis of rotation

Figure A.4 — Configuration of test 3 and test 5

Figure A.5 — Examples of test sample configurations

- 1. Alignment of test samples

The alignment of test samples shall be carried out using the long axes of the upper and the lower arm, determined as follows:

— the longitudinal axis of the upper arm passes through the centres of the shoulder unit and the elbow unit;

— the longitudinal axis of the lower arm passes through the centres of the elbow unit and the wrist unit.

For the distal tensile test, the long axes of the upper and the lower arm shall be aligned closest to being in line.

For the downward and upward bending tests, the shoulder unit shall be locked closest to its neutral position of flexion/extension and adduction/abduction and the elbow unit shall be locked at a flexion angle, at which the long axes of the upper and the lower arm are closest at right angles.

For all tests, the elbow joint centre line shall be aligned perpendicular to the longitudinal axes of the upper and lower arm.

All tests shall be conducted in the worst-case alignment position of the test sample.

The structurally worst alignment position shall, if possible, be defined by the manufacturer/submitter in the test submission document. It shall lie within the limitations of the manufacturer's written instructions for the alignment of the limb, as supplied with every component of that type.

- 1. Orientation marks on test samples

Ensure that samples submitted for test bear marks to indicate “front/anterior”, “outside/lateral”, “upper/proximal”, to correspond with the intended orientation of the prosthesis, when fitted to the user.

Any marks on the test sample shall not affect its strength.

1. Number of tests and test samples required

The minimum number of tests and test samples required is listed in Table A.1.

Table A.1 — Number of tests and test samples required

Type of test		Reference	Minimum number of tests ^a	Batch of test samples allowed for each test
Type of test		Reference	Minimum number of tests ^a	Regular test samples	Possible substitute test samples ^b
Static tests
— distal tensile test	(Test 1	A.8.2	2	2	1
— downward bending test	(Test 2)	A.8.3	2	2	1
— upward bending test	(Test 3)	A.8.4	2	2	1
Cyclic tests
— downward bending test	(Test 4)	A.9.2	1	1	1
— upward bending test	(Test 5)	A.9.3	1	1	1
^a The term “minimum” indicates that the repetition of tests on permitted substitute test samples may be necessary. ^b The number of possible substitute test samples is related to each single test.

1. Multiple use of test samples
  1. General

Test samples that have completed, without failing, any of the tests specified in this annex may be subjected to other tests of this annex, except as stated in A.5.2.

Any decision on the multiple use of test samples should be based on a corresponding indication in the test submission document (see Clause A.6) and/or the agreement between the manufacturer/submitter and the test laboratory/facility.

As a general rule, any failure occurring during a test on a test sample that has been subjected to another test justifies the repetition of the failed test on a substitute test sample (see Table A.1).

- 1. Restriction

Conformity of any test sample with the requirements of the cyclic tests of this annex cannot be claimed if the test sample has previously been subjected to any of the static tests of this annex at a load level required to determine the ultimate strength [see 4.4.4 a) 3)].

1. Test submission document
  1. General requirements

The manufacturer/submitter shall prepare the test submission document with any associated information and shall provide at least one copy with the batch of test samples of every upper-limb prosthetic device submitted for test.

The manufacturer/submitter shall, if appropriate, state in the test submission document which of the information to be recorded in the test log in accordance with this annex shall be included in the test report in addition to the information required to be included according to Clause A.10.

The manufacturer/submitter shall clearly indicate a name and address for communication purposes. If appropriate, the identity of the original equipment manufacturer shall be provided.

The manufacturer/submitter shall provide a unique and traceable identification for the test submission document which shall also be indelibly marked on the test sample. The manufacturer/submitter shall maintain a record of such identification.

The manufacturer/submitter shall clearly indicate the test laboratory/facility required to conduct the test.

The manufacturer/submitter shall clearly indicate the date of submission or dispatch to the test laboratory/facility.

- 1. Information required for test samples

The following information, attributable to a fully traceable identification for each test sample, shall be included in the test submission document:

a) manufacturer's name and model identification and/or number or other means of identification;

b) any certification from the manufacturer, which states that the test sample has been taken from normal production and which gives details of the method of selection in accordance with A.3.2;

c) identification of centres and centre lines in accordance with A.3.3;

d) record of any end attachments (including a socket) or special grip devices in accordance with A.3.3;

e) any special assembly instructions in accordance with A.3.3;

f) identification of the worst-case alignment position in accordance with A.3.4;

g) if appropriate, information on the marks indicating “front/anterior”, “outside/lateral”, “upper/proximal” on each test sample in accordance with A.3.5;

h) if appropriate, information on the multiple use of test samples in accordance with A.5.1.

- 1. Information required for tests

The following information for each test sample shall be included in the test submission document:

The particular test requested (Clauses A.8 and A.9), together with the test load level to be applied (Clause A.8) or the cyclic range of the pulsating test force and the frequency of test to be applied (Clause A.9), respectively.

The following information for each test sample shall be included in the test submission document:

a) the particular test requested (Clauses A.8 and A.9);

b) the relevant loading parameter(s) to be applied, which is/are

1) the test load level for the static tests according to Clause A.8;

2) the cyclic range F_cr of the pulsating test force F_c(t), the preferred frequency of test and the endurance (required number of cycles) for the cyclic test according to Clause A.9.

1. Accuracy
  1. General

Details of methods used to measure accuracy shall be recorded.

Test equipment shall be calibrated at least annually and when any part is replaced. Records of the calibration should be maintained.

- 1. Accuracy of equipment

In order to meet the accuracy of procedure specified in A.7.3, the test equipment should measure:

a) linear dimensions to an accuracy of ±0,2 mm;

b) angular dimensions to an accuracy of ±0,2°;

c) the load to be applied to an accuracy of ±1 % of the highest value required in the test;

d) the frequency of test to an accuracy of ±1 % of the test frequency used.

- 1. Accuracy of procedure

a) Linear dimensions shall be set with a tolerance of ±1 mm.

b) Angular dimensions shall be set with a tolerance of ±1°.

c) Static test forces shall be applied with a tolerance of ±2 % of the highest value prescribed for the test.

d) Pulsating test forces shall be applied at the instant of F_cmin with a tolerance of ±5 N and at the instant of F_cmax with a tolerance of ±3 % of the highest value prescribed for F_cmax.

e) The frequency of test shall be controlled with a tolerance of ±10 % of the test frequency used.

1. Static tests
  1. General

The static tests comprise the distal tensile test specified in A.8.2, the static downward bending test specified in A.8.3 and the static upward bending test specified in A.8.4. The order in which the tests are described is not mandatory for their application.

Keep a log with the test machine during testing and record the test number, the machine reference, the test loads and the dimensions according to Figure A.1, together with the records specifically called for in A.8.2, A.8.3 and A.8.4.

This log forms the basis from which to select the information to be included in the test report (see Clause A.10) in accordance with the test submission document (see A.6.1).

- 1. Distal tensile test (Test 1)

Prepare and align the test sample in accordance with A.3.3 and A.3.4.

If a test sample that has already completed, without failing, any of the other tests specified in this annex is used for this test in accordance with Clause A.5 (see also last paragraph of this subclause), realign it in accordance with A.3.4. Record the re-use of the test sample.

Record the test load level to be applied, specified by the manufacturer/submitter in the test submission document (see A.6.3).

Mount the test sample in the test equipment in accordance with the test configuration illustrated in Figure A.2.

Ensure that any locking mechanisms at the shoulder and/or elbow unit are disengaged.

Apply the test force F at the load application point P (or any appropriate reference point to be specified by the test laboratory/facility) to the lower (distal) end attachment or the special grip device for the terminal device with the load line along or parallel to the long axis of the test sample as illustrated in Figure A.2.

Increase the test force F to the value F_min = 10 N.

Measure and record the initial position of the lower (distal) load application point P (or the specified reference point) on the load line.

Increase the test force F smoothly at a rate of between 1 N/s and 10 N/s. Continuously record the corresponding displacement of the lower (distal) load application point P (or the specified reference point) on the load line from its initial position.

Continue the test until the test force F has reached the test load level specified by the manufacturer/submitter or failure occurs. Record the maximum test force value reached. If failure occurs, record this together with the mode of failure.

Record the final displacement of the load application point P from its initial position, measured either with the test force F = F_min applied or immediately before failure, if this occurs.

If the test is terminated by the operation of an overload release incorporated in the test sample, record this.

If a test sample that has already gone without failing another test specified in this annex fails this test, repeat this test on a substitute test sample and record the failure and the repetition, together with all other records called for.

- 1. Static downward bending test (Test 2)

This test applies only to test samples incorporating an elbow and/or shoulder unit with a locking mechanism or other means of maintaining the angle of flexion/extension.

Prepare and align the test sample in accordance with A.3.3 and A.3.4.

If a test sample that has already completed, without failing, any of the other tests specified in this annex is used for this test in accordance with Clause A.5 (see also last paragraph of this subclause), re-align it in accordance with A.3.4. Record the re-use of the test sample.

Record the test load level to be applied, specified by the manufacturer/submitter in the test submission document (see A.6.3).

Record the initial settings of the (flexion/extension) positions of the shoulder unit and the elbow unit (elbow angle between the long axes of the upper and lower arm), together with the standard settings according to A.3.4.

Mount the test sample in the test equipment in accordance with the test configuration illustrated in Figure A.3.

Apply the test force F at the load application point P to the lower (distal) end attachment or the special grip device for the terminal device with the load line parallel to the long axis of the upper arm segment of the test sample as illustrated in Figure A.3.

Increase the test force F to the value F_min = 10 N.

Measure and record the initial position of the load application point P on the load line.

Increase the test force F smoothly at a rate of between 1 N/s and 10 N/s. Continuously record the corresponding displacement of load application point P along the load line from its initial position.

Record the final displacement of the load application point P from its initial position, measured either with the test force F = F_min applied or immediately before failure, if this occurs.

Measure and record the final settings of the (flexion/extension) positions of the shoulder unit and the elbow unit (elbow angle between the long axes of the upper and lower arm) upon removal of the test sample from the test equipment.

If the test is terminated by the operation of an overload release incorporated in the test sample, record this.

If a test sample that has already completed, without failing, another test specified in this annex fails this test, repeat this test on a substitute test sample and record the failure and the repetition, together with all other records called for.

- 1. Static upward bending test (Test 3)

This test applies only to test samples incorporating an elbow and/or shoulder unit with a locking mechanism or other means of maintaining the angle of flexion/extension.

Prepare and align the test sample in accordance with A.3.3 and A.3.4.

If a test sample that has already completed, without failing, any of the other tests specified in this annex is used for this test in accordance with A.5 (see also last paragraph of this subclause), realign it in accordance with A.3.4. Record the re-use of the test sample.

Record the test load level to be applied, specified by the manufacturer/submitter in the test submission document (see A.6.3).

Mount the test sample in the test equipment in accordance with the test configuration illustrated in Figure A.4.

Increase the test force F to the value F_min = 10 N.

Measure and record the initial position of the load application point P on the load line.

Increase the test force F smoothly at a rate of between 1 N/s and 10 N/s. Continuously record the corresponding displacement of load application point P along the load line from its initial position.

Record the final displacement of the load application point P from its initial position, measured either with the test force F = F_min applied or immediately before failure, if this occurs.

If the test is terminated by the operation of an overload release incorporated in the test sample, record this.

1. Cyclic tests
  1. General

The cyclic tests comprise the cyclic downward bending test specified in A.9.2 and the cyclic upward bending test specified in A.9.3. The order in which the tests are described is not mandatory for their application.

Ensure that the method of applying the pulsating test force F_c(t) to the test sample produces a waveform that is smooth and within the prescribed tolerances [see A.7.3 d) and e)], approximating to a sinusoidal waveform, and that the method of application avoids impact and on removal avoids kickback.

Keep a log with the test machine during testing and record the test number, the machine reference, the test loads, the dimensions, c and d, according to the table in Figure A.1, and the frequency of test. Record on the log the number of cycles completed and any changes observed. Record on the log any adjustments or machine shut-downs together with the number of cycles from the start of the test. Also include the records specifically called for in A.9.2 and A.9.3.

This log forms the basis from which to select the information to be included in the test report (see Clause A.10) in accordance with the test submission document (see A.6.1).

- 1. Cyclic downward bending test (Test 4)

This test applies only to test samples incorporating an elbow and/or shoulder unit with a locking mechanism or other means of maintaining the angle of flexion/extension.

Prepare and align the test sample in accordance with A.3.3 and A.3.4.

Record the cyclic range F_cr = F_cmax − F_cmin of the pulsating test force F_c(t) to be applied, together with the preferred frequency and the endurance (required number of load cycles), specified by the manufacturer/submitter in the test submission document (see A.6.3).

Mount the test sample in the test equipment in accordance with the test configuration illustrated in Figure A.3.

Increase the test force F to the value F_cmin = 10 N.

Measure and record the initial position of the load application point P on the load line.

Apply the pulsating test force F_c(t) determined by the minimum test force F_cmin = 10 N, the cyclic range F_cr specified by the manufacturer/submitter and the maximum test force F_cmax = F_cmin + F_cr at a waveform satisfying the general requirement of A.9.1 and at a maximum frequency of 0,5 Hz for a minimum of 300 000 cycles.

Measure with the test force F_cmin applied and record the final displacement of load application point P from its initial position.

If any part of the structure of the test sample fails in the cyclic test, the test sample does not satisfy the requirement of this subclause (but see last paragraph).

Record failure of the test sample together with the number of load cycles achieved.

Visually examine any test sample satisfying the test requirements and record any signs of damage in the log.

- 1. Cyclic upward bending test (Test 5)

This test applies only to test samples incorporating an elbow and/or shoulder unit with a locking mechanism or other means of maintaining the angle of flexion/extension.

Prepare and align the test sample in accordance with A.3.3 and A.3.4.

If a test sample that has already completed, without failing, any of the other tests specified in this annex is used for this test in accordance with A.5 (see also last paragraph of this subclause), re-align it in accordance with A.3.4. Record the re-use of the test sample.

Mount the test sample in the test equipment in accordance with the test configuration illustrated in Figure A.4.

Increase the test force F to the value F_cmin = 10 N.

Measure and record the initial position of the load application point P on the load line.

Measure with the test force F_cmin applied and record the final displacement of load application point P from its initial position.

If any part of the structure of the test sample fails in the cyclic test, the test sample does not satisfy the requirement of this subclause (but see last paragraph).

Record failure of the test sample together with the number of load cycles achieved.

Visually examine any test sample satisfying the test requirements and record any signs of damage on the log.

1. Test report
  1. General requirements

The test laboratory/facility shall prepare a test report for the test(s) conducted and should provide at least one copy of the test sample, to the submitter.

The test laboratory/facility shall maintain another copy of the test report with the test log. This will simplify the reply to possible further inquiries of the manufacturer/submitter.

The test report shall be signed on behalf of the test laboratory/facility by a designated person.

The test laboratory/facility shall clearly indicate a name and address for communication.

The test laboratory/facility shall provide a unique and traceable identification for the test report (such as serial number) including identification of each page, and the total number of pages of the report. The test laboratory/facility should maintain a record of such identification.

The submitter of the test sample and the test laboratory/facility identification shall be clearly indicated.

The date of receipt of test samples and date(s) of preparation of the test report shall be clearly indicated.

- 1. Specific requirements

For each type of test conducted (see Table A.1), the test report shall specifically refer to Annex A of this document, the subclauses related to the specific type of test performed (see A.8.2, A.8.3, A.8.4, A.9.2 or A.9.3), the test loading conditions applied (test load level for static tests or pulsating test force, test frequency and endurance for cyclic tests), and which special test set-ups were used.

For each upper-limb prosthetic device for which an appropriate batch or batches of test samples have been submitted for test, the test report shall state the tests in which compliance with requirements of this annex has been demonstrated. The test report shall also state the tests conducted, in which compliance has not been demonstrated.

- 1. Options

The test report shall include any additional information, specifically requested in the test submission document (see A.6.1).

Upon request of the submitter, the test laboratory/facility shall copy from the test log (see A.8.1 and A.9.1) to the test report any further records of samples and test results called for.

(informative)

Guidance on methods of determining the mechanical properties of knee joint assemblies for lower-limb orthotic devices

The manufacturer shall define the structural testing, test method, justification and document the test result.

Common parts for structural integrity are liable to the adaptation for individual user and although general test method defined above will cater for safety for structural strength, further local, documented, risk analysis may be applicable for adapting parts. Structural strength for worst case loading e.g. with minimal support from intact limb, or extreme alignment, should be considered and documented.

For example, most lower limb orthosis (e.g. KAFO ) are applied to an intact lower limb, the level of support available from the intact limb can vary considerably depending on the condition to be treated , hence, a dummy leg can be constructed and common component applied to the dummy leg to simulate the structural loading of the orthosis. The level of load can be stipulated by the manufacturer depending on application, and ISO 10328 and 22675 could provide guidance for percentage of load to be applied.

Any justification for selection of test method and load level are documented. Additional testing, e.g, torsional testing may also be required to reflect the particular loading conditions that may be applied by the Orthotic user.

(informative)

Guidance on methods of determining the flammability and toxicity of combustion products of lower-limb prosthetic devices
1. General

It is important that whenever potentially flammable materials are present and where there is the risk of fire occurring and of people being exposed to combustion products, the hazards shall be minimized. In the case of lower limb prostheses, there is a risk of fire by contact with a hot surface or by exposure to flame.

The majority of injuries in fire are caused by the smoke and toxic/irritant gases produced; the remainder are caused by burns. The toxic hazard comprises the toxic effect of smoke and gas produced during combustion and the rate at which they are produced, which is a function of the flammability characteristics of the burning materials.

This annex gives guidance on methods for assessing the ignition and burning characteristics (including toxic hazard) of lower-limb prosthetic devices when subjected to radiant and naked flame heat sources. This document does not include tests where the prosthetic device is covered by clothing.

1. Principle

The principle is to subject complete prosthetic devices to two separate tests; a radiant heat source test (i.e. without flame) and a naked flame source test (as described in ISO 8191-2).

1. Test submission document

A test submission document identifying the test sample shall be supplied by the manufacturer/submitter. If a test sample is submitted by the manufacturer, the test submission document shall identify all materials, cosmesis, covers, adhesives, fastenings, etc. used in the construction of the test sample.

1. Safety requirements

There are hazards encountered when conducting fire tests and it is essential that adequate precautions be taken.

Pay particular attention to the handling of flammable gases, the evolution of potentially toxic gases and the fact that extensive inflaming of test samples may occur.

Provide adequate means of extinguishing the test sample, bearing in mind that some test samples may produce severe flaming during the test. Ensure that a hand-held CO₂ fire extinguisher that can be directed over the burning area is available.

NOTE In some cases, smouldering can be difficult to extinguish completely and immersion of the test sample in water can be necessary.

1. Test samples
  1. Sample, nature and source

Complete lower-limb prosthetic devices shall be tested, although surrogate skeletal components may be used if it can be shown that these would not affect the test results.

If submitted by the manufacturer, a test sample should in all other respects be fully representative of the manufacturer's sealed design/specification and proposed or actual production standard. The manufacturer should furnish evidence to confirm that the samples are in accordance with the specified design and that quality assurance requirements controlling materials have been met.

All combinations of materials, cosmesis, covers etc. supplied as test samples shall represent typical lower‑limb prosthetic assemblies that it is proposed to supply.

- 1. Sample identification

Ensure that the test samples are clearly identified by the manufacturer/submitter and where submitted by the manufacturer, all interfaces between differing materials that make up the cosmesis/finished article (including foot cosmesis) are clearly shown and/or indelibly marked on the outer cosmetic covering. Ensure that these locations, if present, are recorded on the test submission document. Ensure that the sample identification bears the manufacturer's/submitter's name and a reference number traceable to the test submission document.

- 1. Sample dimensions

Build all test samples of lower-limb prosthetic devices in accordance with the dimensions given in Figures C.1 and C.2. Use standard size “dummy” sockets for both trans-tibial and trans-femoral test samples (see Figures C.3 and C.4).

- 1. Sample conditioning

Condition test samples before test for at least 4 d at a temperature of (23 ± 2) °C and a relative humidity of (50 ± 5) % (see NOTE 1) and until constant mass is achieved (see NOTE 2). Report the final mass.

Arrange the test samples within the conditioning environment so that air can circulate around each side of each test sample.

NOTE 1 These conditions correspond to the atmosphere described in ISO 554.

NOTE 2 Constant mass is considered to be reached when two successive weighing operations, carried out at an interval of 24 h, do not differ by more than 0,1 % of the last mass of the test sample, or 0,12 g whichever is the greater in terms of mass.

1. Test arrangements
  1. Test room

Ensure that the test room

— is of sufficient size to easily accommodate all test equipment and apparatus and to allow space for access on all sides;

— is capable of being sealed to prevent draughts;

— has a suitable extraction system to allow smoke and fumes to be removed quickly and safely following a test;

— allows the test to be viewed clearly by observers and/or video/photographic means.

Provide means of extinguishing any burning samples.

Ensure that the room temperature at commencement of each test is (20 ± 10) °C.

Observers and control and monitoring equipment shall be located outside the room.

- 1. Sample support frame

Provide a suitable support frame/clamp to enable the test sample to be held in the required position and orientation for both radiant and flame exposure heat sources.

With the radiant source test retain the sample in one position (i.e. horizontally and parallel to the heat source elements, as shown in Figure C.5).

With the flame impingement test apply the flame so that the “worst case” point of application and sample orientation is tested; this requires different orientations to be assessed.

NOTE 1 This “worst case” will usually be with the flame impinging underneath the sample with the latter inclined to the horizontal (see Figure C.6).

Ensure that the support frame for the radiant exposure test allows the mass loss from the sample to be measured.

NOTE 2 To accommodate limbs of varying length at horizontal or inclined orientations, a support frame constructed from slotted angle members has been found to be suitable. This is mounted on the platform of a large capacity laboratory top-pan balance (60 kg capacity), in the form of a rectangular section frame about 900 mm high. Pulleys carried on projecting arms at the top of the frame carry suspension wires at about 200 mm beyond the edge of the balance (see Figure C.7). Wire loops are formed through holes drilled in the rim of the socket and at the toe of the limbs which are suspended from the wires via intermediate lengths of suitable wire to achieve approximate positioning. Final adjustments are to be made on length adjustors incorporated in the main suspension wires.

- 1. Apparatus
    1. Radiant heat source

Ensure that the electric radiant heat source is capable of providing a constant radiative heat flux of 20 kW/m² at the closest point of the test sample and between 15 kW/m² and 18 kW/m² at a lateral distance of 100 mm on each side of this point.

Ensure that the heat source reaches 60 % of full power within 1 min of switch-on and full power within 4 min to 5 min.

To ensure repeatability of intensity and location of the radiative heat flux either

a) provide a variable power input to the heat source so that the prescribed heat flux is produced at a known distance from it, e.g. 100 mm and at a known height (above the working surface), or

b) use an uncontrolled heat source working directly from the mains electrical supply connected to a voltage stabilizer (if required) and determine the location where the prescribed heat flux is achieved, and use this distance as the separation between source and sample in all tests.

Regularly check the radiative heat flux in the plane of the sample with a calibrated heat flux meter.

NOTE Two quartz halogen lamps each of 2 kW power mounted in reflectors have been found to be sufficient. A suitable arrangement is shown in Figure C.5.

- - 1. Flame ignition source

This ignition source is a diffusion flame with a calorific output approximating that of a burning match. A flame exposure time of (15 ± 1) s will be approximately equivalent to the burning of one match. A burner tube consists of a length of stainless steel tubing of (8,0 ± 0,1) mm outside diameter, (6,5 ± 0,1) mm internal diameter and (200 ± 0,5) mm in length. The flow meter shall be calibrated to supply a propane gas flow rate at 25 °C of (45 ± 2) ml/min.

The burner tube is connected by flexible tubing to a flow meter fitted with a flow controller and in turn to a butane gas cylinder fitted with a standard commercial 100 kPa pressure regulator. The flexible tubing between the flow meter and the tube has a nominal internal diameter of 8 mm and a length of (2,0 ± 0,2) m.

NOTE 1 100 kPa = 1 bar.

NOTE 2 Under the above conditions, the flame height from the burner is approximately 40 mm and the heat flux applied to the test sample is (40 ± 2) kW/m².

For remote control, incorporate a solenoid cut-off in the burner tube and locate some form of electrical igniter at the burner mouth.

Mount the burner assembly on a suitable carrier sliding on a moveable track and capable of being moved along the track from a remote position (e.g. with a pull string operated from an adjoining control room).

NOTE 3 The moveable track provides a positive location point for the burner tube when setting up the test while enabling it to be removed for checking flame height and solenoid operation etc., as necessary.

In the case of local control omit the solenoid cut-off and electrical igniter and control the test flame manually.

Mount the burner on a carrier on a track as above, so that a positive location for the flame in relation to the sample can be established prior to the test. Retract the burner, ignite and adjust the flame and then move it into the test position for starting the test.

Use adequate respiratory protection, as necessary.

Make video/photographic records of the tests, if required by the manufacturer/submitter.

- - 1. Weighing platform

Use a calibrated weighing platform of suitable capacity and with a resolution of 1 g to measure the mass loss of the sample with time elapsed for the duration of the test.

Ideally, output to a suitable remotely connected device such as a data logger or a chart recorder should be available or else visual observation and recording would be satisfactory if visual access is adequate. A calibration check should be carried out before each series of tests.

- - 1. Video/photographic recording

Video/photographic records should be made of tests.

1. Test procedures
  1. General

Ensure that test operators are competent to safely carry out the test.

Make a check to ensure that operators cannot be exposed to fumes from combustion.

Before commencing, check all equipment for correct operation.

Ensure that the test room can be cleared of smoke and decomposition products by an extractor fan or other means of ventilation, bearing in mind that the testing room atmosphere may become hazardous.

Provide adequate means of extinguishing the test sample, bearing in mind that severe flaming may be encountered. Ensure that a hand-held CO₂ extinguisher that can be directed over the burning area is available with other means, such as fire blankets.

NOTE In some cases, smouldering can be difficult to extinguish completely and immersion of the test sample in water may be necessary.

- 1. Radiant heat source

Drill holes at the top of the socket and at the toes and form wire loops through them for attachment to the suspension wires.

Connect each end of the sample with a string or thread stretched over the outer surface of the limb so that it touches the “high points” and delineates a datum line along the length of the sample.

Suspend the sample from the suspension wires to the sample support frame and adjust the positioning of the limb so that the datum is at the pre-determined height providing the required heat flux is at the closest point from the radiant heat source.

NOTE 1 A ruler or a strip of metal scribed at this height can be used as a gauge.

Locate the heater parallel to the datum at the pre-determined distance of approximately 100 mm to achieve the prescribed heat flux.

NOTE 2 A simple gauge can be made from a piece of 3 mm metal rod cut to this length and held in a T-handle.

Remove the string, switch on all recording equipment and start the test by applying power to the heat source.

During the test

a) record whether sustained flaming lasting longer than 4 s occurs;

b) record the mass loss at one 1 min intervals for the duration of the test, maintain the heating for 30 min or until thermal decomposition is judged to have stopped as assessed both visually and from mass loss measurements;

c) record whether debris separates and whether it is flaming or glowing.

Conduct further tests at different locations along the test sample to coincide with the interface of differing materials and/or specified areas such as calf and thigh.

NOTE 3 It can be necessary to use separate samples for different interface tests.

NOTE 4 The test sample can produce molten material which could detach and this should be taken into account while measuring mass loss. A simple tray suspended from the test sample support frame has been found to be adequate.

- 1. Flaming ignition source

Adjust the height of the limb on its suspension wires until the selected test area is located 39 mm vertically above the mouth of the burner, with the burner carrier positively located on its track.

NOTE 1 A retractable wire gauge 39 mm in height located on the burner tube is suggested for the final adjustment of the limb height.

Retract the burner along its track.

Establish the test flame and adjust to 41 mm using the wire gauge on the burner as a guide.

Withdraw the height marker gauge and position the burner under the test area.

Start the test by applying the burner flame for 15 s.

Note whether the propagation of flaming extends beyond the influence of the flame ignition source.

Extinguish or withdraw the flame at the expiry of the test period.

Observe the test sample after this point until it is apparent that no self-sustained flame/or flaming combustion is occurring and there is no evidence of continuing thermal decomposition.

Extinguish the sample if sustained flaming combustion persists for longer than 15 s after the removal of the flame ignition source.

Apply the flame at various points on the sample if the “worst case” situation has not been established.

NOTE 2 An angle of 45° to the horizontal as shown in Figure C.6 will normally be the “worst-case” impingement/orientation.

NOTE 3 Locations for application of the flame ignition source may be decided through consultation between the test laboratory and the manufacturer/submitter.

1. Determination of the “Total Toxic Potential Dose” (TTPD)
  1. Rationale for the toxicity criterion based on mass loss

Although the toxic potency of the fire atmosphere arises from a wide variety of different chemical species, results from toxic potency tests suggest that the toxic potency based on the extent of conversion of the “fuel” to products during combustion (i.e. as measurable from the mass loss of the fuel) is relatively similar for many different materials. The range of toxic potency values for many common materials, both natural and synthetic, lies approximately between an LCt₅₀ of 100 g·m⁻³·min to 2 000 g·m⁻³·min where the LCt₅₀ is defined as “A measure of lethal toxic potency; the exposure dose calculated to produce lethality in 50 % of exposed test animals within a specified exposure time and post-exposure observation period. This measure can be used to compare the toxic potencies of the combustion products from different materials decomposed under different fire conditions”.

The criterion adopted in this annex uses the method described in BSI DD180^[17] to calculate the cumulative “Total Toxic Potential Dose” (TTPD) with time, based on the cumulative mass loss of the sample over fixed time periods. In BSI DD180, a value of total toxic potential dose of 200 g·m⁻³·min is considered “incapacitating” and a value of 500 g·m⁻³·min “life threatening”. For the purposes of this International Standard, a value of the total toxic potential dose of 100 g·m⁻³·min is used as the pass/fail criterion, i.e. a value equal to or higher than 100 g·m⁻³·min would constitute a fail. To enable the assessment to be made solely on the basis of cumulative mass loss, a fixed volume into which the fumes would be dispersed has to be set. For the purposes of this document the reference volume V_R = 30 m³, representative of a typically sized domestic room, should apply.

- 1. Calculation of the “Total Toxic Potential Dose” (TTPD)

In order to calculate the total toxic potential dose, proceed as follows (a worked example is included as Table C.1).

Step 1:	Tabulate the cumulative mass loss in grams of the sample, achieved after each successive minute of the test up to 30 min.
Step 2:	Divide each cumulative mass loss after each time interval by 30 to achieve the toxic potential concentration (units: g·m⁻³).
	NOTE The reference volume V_R = 30 m³ is representative of a typically sized domestic room (see C.8.1).
Step 3:	Add each successive value obtained in Step 2 to its previous value, i.e. to achieve a cumulative total toxic potential dose.
Step 4:	Check the value of cumulative total toxic potential dose reached by the end of the test period against the specified limit to decide on whether the sample has passed or failed the radiant heat source test (see C.9.1).

1. Pass/fail criteria
  1. Radiant heat source test

Failure is deemed to occur if there is an appearance of sustained flaming combustion during the test. If no flaming occurs a TTPD, calculation should be performed using the mass loss data in the method described in C.8. If the TTPD is equal to or greater than 100 g·m⁻³·min, the sample is deemed to have failed.

- 1. Flaming ignition source test

Failure is deemed to occur if for any application point or sample orientation

— propagation of flaming takes place away from the influence of the flaming ignition source during the 15 s flame ignition source applications, or

— if flaming combustion is still occurring 15 s after the removal of the flaming ignition source.

1. Test report

Record the identification of the test sample and the test submission document in a test report together with all relevant information recorded during the test. Specifically refer this annex. Issue at least one copy of the test report to the submitter.

Dimensions in millimetres

^a	Ankle to knee centre.
^b	Knee centre to ischium.

Level

Circumference

TU (upper thigh)

TM (mid thigh)

TL (lower thigh)

K (knee)

C (calf)

A (ankle)

660

550

440

430

400

235

Foot size 290 mm.

NOTE The shape of the thigh cross section can be circular. The shape of the below knee section should conform with normal cosmetic cover manufacturing practise to ±5 %.

Figure C.1 — Test sample dimensions trans-femoral (above-knee) — Finished limb

Dimensions in millimetres

^a	Ankle to knee centre.

Level

Circumference

K (knee)

C (calf)

A (ankle)

430

400

235

Foot size 290 mm.

NOTE The shape of the below knee section should conform with normal cosmetic cover manufacturing practise to ±5 %.

Figure C.2 — Test sample dimensions trans-tibial (below-knee) — Finished limb

Dimensions in millimetres

Figure C.3 — Test sample dimensions trans-femoral (above-knee) — Socket former

Dimensions in millimetres

Figure C.4 — Test sample dimensions trans-tibial (below-knee) — Socket former

Dimensions in millimetres


a) lateral view	b) frontal view

Key

1 nichrome suspension wires

2 radiant heat sources (e.g. 2 kW quartz halogen lamps)

3 reflectors angled to focus radiation at P_HF

4 point of measured heat flux, P_HF

5 datum line indicating the “high points” of the sample

NOTE Holes for the nichrome wires are predrilled in the test sample at the locations shown (e.g. socket rim and keel of foot).

Figure C.5 — Radiant heat source test

Dimensions in millimetres

Key

1 nichrome suspension wire

2 flame ignition source

NOTE 1 The flame ignition source is situated so as to apply the flame so that the “worst-case” point of application and sample orientation is tested as specified in C.6.2.

NOTE 2 Holes for the nichrome wires are predrilled in the test sample at the locations shown (e.g. socket rim and keel of foot).

Figure C.6 — Flaming ignition source test

Dimensions in millimetres


a) side elevation	b) front elevation

Key

1 limb position indicated for radiant heat source test

2 suspension wires

3 wire loops at toe and socket rim

4 length adjusters

Figure C.7 — Sample support frame and weighing platform

Table C.1 — Worked example of calculating the TTPD

Time	Cumulative mass loss at end of period	Toxic potential concentration	Total Toxic Potential Dose
min	(A) g	(A/30) ^a g·m⁻³	g·m⁻³ min
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30	6 10 15 25 35 40 50 55 60 65 68 72 75 78 80 82 84 86 87 88 89 89 90 90 90 91 91 91 92 92	0,20 0,33 0,50 0,83 1,17 1,33 1,67 1,83 2,00 2,17 2,27 2,40 2,50 2,60 2,67 2,73 2,80 2,86 2,90 2,93 2,97 2,97 3,00 3,00 3,00 3,03 3,03 3,03 3,06 3,06	0,20 0,53 1,03 1,86 3,03 4,36 6,03 7,86 9,86 12,03 14,30 16,70 19,20 21,80 24,47 27,20 30,00 32,86 35,76 38,69 41,66 44,63 47,63 50,63 53,63 56,66 59,69 62,72 65,78 68,84
NOTE As shown in Table C.1, a TTPD value of 100 was not reached at 30 min constituting a pass. ^a The values A/V of the toxic potential concentration are related to the reference volume V_R = 30 m³ representative of a typically sized domestic room.

(informative)

Guidance on methods of establishing the force or moment required to operate the control and actuating mechanisms on prosthetic and orthotic devices
1. General

NOTE The test methods specified in this annex have been developed since the ranges of operating force specified in EN 614-1 and/or other standards referred to therein such as EN 894-3 are not necessarily applicable to the control and actuating mechanisms on prosthetic and orthotic devices.

In order to establish a data base for orientation (see Clause D.7), the test methods specified in this annex have been applied to a selection of state of the art prosthetic and orthotic devices, including samples of all categories specified in D.3.1, except category k).

Many prosthetic and orthotic devices incorporate mechanisms designed to permit the user to control the characteristics of the functional components of these devices. The most common of these are the locks on prosthetic and orthotic joints or units. Another relevant group of prosthetic devices comprises terminal devices (e.g. prosthetic hands or hooks). Typically, the operation of the mechanisms of these devices requires the application of a force or moment through some form of actuator either directly or in some instances through a linkage or cable to the mechanism.

Other prosthetic devices require the application of a force or moment to articulate, rotate or separate them or to activate their fail-safe release unit.

The method of application of the operating force or moment and its optimal line of application will depend on the design of the mechanism.

This annex describes a method of establishing the required operating force when applied in the manner intended by the manufacturer to the actuator normally supplied with the mechanism.

It does not include any evaluation of the design of the actuator/operator interface.

The tests described should be repeated whenever significant design changes are made to the control or actuating mechanisms in a prosthetic or orthotic device.

1. Principle

The test procedures are intended to assess the force or moment required to operate the control or actuating mechanism on the test sample in a position and subject to external loading which is consistent with both the manufacturer's intentions and established user practice. For this purpose, 11 different test set-ups are specified in D.6.2 to D.6.12, each suitable for testing one of the eleven categories of test samples of prosthetic or orthotic devices incorporating control or actuating mechanisms specified in D.3.1 a) to k).

The method of operating the control or actuating mechanisms of other functional components of prosthetic and orthotic devices is highly variable and depends on the design and function of the components. Methods of establishing the force or moment required to operate such mechanisms should be based on the general principles stated above and follow the procedures relating to positioning and loading described in D.6.1 to D.6.12 for tests on knee joints and units, elbow joints and units and terminal devices.

1. Test samples
  1. Categories of test sample

a) Test samples of orthotic knee joints with locking mechanism — these are sub-assemblies comprising the lower leg side bar, the joint and its locking mechanism, and the upper leg side bar.

b) Test samples of orthotic elbow joints with locking mechanism — these are sub-assemblies comprising the lower arm side bar, the elbow joint and its locking mechanism, and the upper arm side bar.

c) Test samples of prosthetic knee units with locking mechanism — these are sub-assemblies comprising the socket attachment component, the knee unit and its locking mechanism, and all associated structural components below the knee unit, including the foot if preferred (see NOTE 4 of D.3.2).

d) Test samples of prosthetic elbow units with locking mechanism — these are sub-assemblies comprising the socket attachment component, the elbow unit and its locking mechanism, and all associated structural components below the elbow unit including a terminal device.

e) Test samples of prosthetic elbow units with user-driven articulation — these are sub-assemblies comprising the elbow joint's attachment component, the elbow joint and its actuating mechanism, and all associated structural components below the elbow unit, including the terminal device.

f) Test samples of prosthetic terminal devices with built-in closing function — these are sub-assemblies comprising the hand or hook and its actuating mechanism, and a substitute for the lower arm socket or side bar.

g) Test samples of prosthetic terminal devices with built-in opening function — these are sub-assemblies comprising the hand or hook and its actuating mechanism, and a substitute for the lower arm socket or side bar.

h) Test samples of prosthetic terminal devices with no built-in closing or opening function, actuated by force application — these are sub-assemblies comprising the hand or hook and its actuating mechanism, and a substitute for the lower arm socket or side bar.

i) Test samples of prosthetic terminal devices with no built-in closing or opening function, actuated by torque application (rotation of the lower arm relative to the socket) — these are sub-assemblies comprising the hand or hook and its actuating mechanism, and a substitute for the lower arm socket or side bar.

j) Test samples of prosthetic terminal devices with break-open features for emergency situations — these are sub-assemblies comprising the hand or hook, and a substitute for the lower arm socket or side bar.

k) Test samples of prosthetic devices with fail-safe release units — these are sub-assemblies comprising the prosthetic device and its fail-safe release mechanism, and all adjacent associated structural components below and above the device.

- 1. Preparation of test samples

Select the prosthetic and orthotic devices for testing from the normal production.

Samples selected for testing should bear orientation marks to indicate their anterior/front, lateral/outside and upper/proximal surfaces when assembled in a prosthetic or orthotic device in its position of intended use.

The intended line of action of the actuator force should be identified on the sample.

Assemble each test sample from the components listed for that category in D.3.1 a) to k).

When preparing test samples of prosthetic knee and elbow units, omit cosmetic components unless they affect the operation of the locking mechanism and/or contribute to the total mass of the test sample by more than 10 %.

When preparing test samples incorporating orthotic joints or prosthetic units of polycentric design, establish whether the manufacturer has specified the position of a reference axis to be used for orientation instead of the position of the axis of rotation of a corresponding monocentric type.

NOTE 1 If appropriate, the position of the reference axis of orthotic joints or prosthetic units of polycentric design, to be used for orientation instead of the position of the axis of rotation of a corresponding monocentric type, are to be marked on the sample or otherwise identified.

When preparing test samples of prosthetic knee units, decide on whether or not they should include an ankle-foot device.

NOTE 2 According to the experience gained during laboratory tests, the influence of ankle-foot devices in test samples of prosthetic knee units on the test results is negligible.

Provide test samples of categories D.3.1 a) to i) with a proximal end attachment and test samples of categories D.3.1 j) and k) with a distal end attachment specified by the test laboratory to permit mounting in the test rig in the relevant manner described in Clause D.6.

NOTE 3 For test samples of prosthetic devices a socket can be used, partially filled to provide an end attachment.

If the distal end attachment of test samples of categories D.3.1 j) and k) incorporates a force transducer (or should be connected to one), ensure that this is (or can be) arranged so that the test force is acting along its measuring axis when applied in the manner described in D.6.1.

When preparing test samples of orthotic knee joints or prosthetic knee units, set the total length proximal and distal to the knee axis of rotation (or reference axis) by following either of the following procedures.

a) If appropriate, adjust or adapt the total length to 450 mm (see NOTE 4).

b) If it is desirable to avoid such adaptations, approximate the total length to 450 mm as far as possible (see NOTE 5).

NOTE 4 Adapting of the total length of test samples of orthotic knee joints or prosthetic knee units to 450 mm can require cutting of side bars or pylons.

NOTE 5 Approximating of the total length of test samples of orthotic knee joints or prosthetic knee units to 450 mm will usually be achieved by selecting the components adjacent to the orthotic knee joint or prosthetic knee unit with the most suitable length.

Ensure that the test samples include any remote actuator and cable or linkage normally required to operate the control or actuating mechanism.

If a remote actuator is connected to the control or actuating mechanism by a (Bowden) cable, observe the following procedures (but see NOTE 6).

— Arrange the cable between the actuator and the control or actuating mechanism so that it undergoes a double 180° bend (or S-bend) with a bending radius of about 50 mm as illustrated in Figures D.1 and D.4.

— If a remote actuator is part of a control or actuating mechanism of test samples of orthotic knee joints or prosthetic knee units, position it at a distance e = 400 mm proximal to the knee axis of rotation (or reference axis) as illustrated in Figure D.4.

If the remote actuator cannot be positioned, and/or the (Bowden) cable cannot be arranged, as specified in the above paragraph (see NOTE 6), arrange the (Bowden) cable as described in the paragraph following NOTE 6.

NOTE 6 Laboratory tests have shown that it is not always possible to position the remote actuator and/or to arrange the cable as specified. In this case the cable should be arranged as described in the following paragraph.

If a remote actuator is connected to the control or actuating mechanism by a cable (wire) or linkage, ensure that the operating force to be applied to the remote actuator is transmitted through the cable (wire) or linkage in the direction/manner intended by the manufacturer and/or appropriate for its specific design, e.g.

— for designs such as “drop” or “ring” locks this force needs to be applied exactly in the direction of the operating movement/translation, otherwise jamming may occur;

— for lever type locks this force is usually applied at right angles to the lever.

Align any actuation toggles so as to minimize the force required to operate the lock.

If appropriate, adjust locking mechanisms so that they are in the fully engaged position as described by the manufacturer of the joint assembly.

Precondition the test sample by alternately engaging and disengaging its control or actuating mechanism at least ten times.

1. Number of required tests

Subject two samples of the prosthetic or orthotic device to each relevant test.

1. Accuracy

Ensure that

— linear dimensions are within ±1 mm,

— angular dimensions are within ±1°, and

— loads are within ±5 % of the prescribed value.

1. Methods of testing
  1. General

Before commencing any one of the test procedures specified in D.6.2 to D.6.12, ensure the following:

— each test sample is assembled and prepared in accordance with the relevant instructions of D.3.2;

— the operating force is applied to the actuator in the direction/manner intended by the manufacturer and appropriate to its specific design or, if not stated, the operating force is applied parallel to (or along – see last paragraph and NOTE 2) the axis of the prosthetic device's adaptor;

— the operating moment is applied to the actuator in the orientation intended by the manufacturer or, if not stated, the operating moment is applied about the axis of the prosthetic device's adaptor;

— the locking mechanism of the test sample is fully engaged, since incomplete engagement invalidates the tests.

When applying an operating force to the actuator of test samples in the direction intended by the manufacturer, take into account the following.

— If the principal operating movement of the control or actuating mechanism is translation of a component (as e.g. the locking movement of “drop” or “ring” locks), ensure that the operating force is applied to that component exactly in the direction of its translation in order to avoid jamming.

— If the principal operating movement of the control or actuating mechanism is rotation of a component (as e.g. the locking movement of lever type locks), ensure that the operating force is applied perpendicular to its axis of rotation and at a known perpendicular distance, d, from this axis (see NOTE 1).

NOTE 1 The lever length of lever type locks for similar application is known to differ from each other in the industrially pre-fabricated state of manufacturing, depending on the design concept applied, including the possibility of individual adaptation of lever length and shape. Therefore, the assessment or comparison of the physical effort for the operation of such mechanisms can require the calculation of the operating moment as the product of the operating force and its perpendicular distance, d, from the axis of rotation of the lever, on which it acts.

When applying an operating moment to the actuator of test samples in the orientation specified by the manufacturer, take into account the following.

— If the principal operating movement of the control or actuating mechanism is axial rotation, ensure that the moment is applied to that component as a force couple about its axis of rotation.

When applying a tensile force to test samples of prosthetic terminal devices with break-open features or prosthetic devices incorporating fail-safe release units, ensure that this force is applied exactly in the specific direction of translation required to make the break open or fail-safe release mechanism operate.

NOTE 2 This direction may (initially) coincide with the axis of the prosthetic device's adaptor.

- 1. Test set-up for sample category: Orthotic knee joints with locking mechanism

Position the test sample of an orthotic knee joint as shown in Figure D.2, i.e.

— with the axis of rotation (or reference axis) of the joint horizontal,

— with the long axis of the assembly inclined at β = 40° to the horizontal,

— with the frontal face of the assembly pointing upwards, and

— with the distal end of the sample resting on a horizontal surface in a manner providing low friction.

Support the proximal end of the sample in a pin joint.

Apply a vertical force, F_m1 to the distal segment of the test sample at a distance, c, from the knee axis of rotation (or reference axis) as illustrated in Figure D.2 and specified in Table D.1 for the relevant test set-up.

NOTE 1 The vertical force F_m1 is applied to the test sample to represent the weight of the normal body parts to which the device would be attached.

NOTE 2 To ensure that the vertical test force F_m1 applied produces a uniform effect, the value of the distance, c, needs to be adapted to test set-ups with segmental lengths of the test sample differing from a = b = 450 mm.

Apply the operating force F_op to the actuator of the test sample in accordance with D.6.1.

Increase the operating force F_op at a rate not exceeding 10 N/s until the locking mechanism disengages.

NOTE 3 The disengagement of the locking mechanism may be tested manually by attempting to flex the joint.

Record the value of operating force, F_op1 at which the locking mechanism disengages, together with the value of the distance, d₁, of the line of action of F_op1 from the axis of the actuating lever (if present) at the instant of disengagement, if appropriate (see NOTE 1 of D.6.1).

Relock the knee joint and repeat the test procedure five times.

Calculate the mean of the values of operating force F_op1 measured in the six tests.

Repeat the six tests with a vertical force F_m2 applied to the test sample.

NOTE 4 The vertical force F_m2 is applied to the test sample to simulate the effect of a force applied manually by the user to the front of the thigh to create a knee extension moment.

Record the value of operating force F_op2 at which the locking mechanism disengages, together with the value of the distance, d₂, of the line of action of F_op2 from the axis of the actuating lever (if present) at the instant of disengagement, if appropriate (see NOTE 1 of D.6.1).

Calculate the mean of the values of operating force F_op2 measured in the six tests.

Carry out the entire test procedure on a second test sample.

Calculate and record as the final test result the mean of the values of operating force F_op measured in both test series.

NOTE 5 For specific designs of orthotic knee joints it can also be of interest to establish the operating force required to engage the locking mechanism. For such designs the procedure of D.6.2 may be adapted for this purpose.

Table D.1 — Parameters of the test set-up for sample category D.3.1 a)

Test set-up	Segmental lengths of test sample		Distance of load application point from knee axis	Vertical force
Test set-up	a mm	b mm	c mm	F_m1 N	F_m2 N
Regular	450	450	280	60	120
Individual	a_i	b_i	c_i = b_i − 85(1 + b_i/a_i)	60	120

- 1. Test set-up for sample category: Orthotic elbow joints with locking mechanism

Position the test sample of an orthotic elbow joint with the upper arm side bar vertical and the lower arm side bar locked horizontally (see Figure D.3). If the design of the test sample does not allow these positions to be achieved in one test set-up, set the lower arm side bar horizontal and the upper arm side bar as close as possible to the vertical.

Ensure that there is no other support for the elbow joint or the lower arm side bar.

Apply a vertical force, F_m = 20 N, to the distal segment of the test sample at a distance, c = 120 mm, from the elbow axis of rotation (or reference axis) as illustrated in Figure D.3.

NOTE 1 The vertical force, F_m is applied to the test sample to represent the weight of the normal body parts to which the device would be attached.

Apply the operating force, F_op to the actuator of the test sample in accordance with D.6.1.

Increase the operating force, F_op at a rate not exceeding 10 N/s until the locking mechanism disengages.

Record the value of operating force, F_op1 at which the locking mechanism disengages, together with the value of the distance, d₁, of the line of action of F_op1 from the axis of the actuating lever (if present – see NOTE 2) at the instant of disengagement, if appropriate (see NOTE 1 of D.6.1).

NOTE 2 The operation of the type of locking mechanism on the sample of orthotic elbow joint shown in Figure D.3 does not require an actuating lever.

Relock the elbow joint and repeat the test procedure five times.

Calculate the mean of the values of operating force F_op1 measured in the six tests.

Carry out the entire test procedure on a second test sample.

Calculate and record as the final test result the mean of the values of operating force F_op measured in both test series.

NOTE 3 For specific designs of orthotic elbow joints it can also be of interest to establish the operating force required to engage the locking mechanism. For such designs the procedure of D.6.3 may be adapted for this purpose.

- 1. Test set-up for sample category: Prosthetic knee units with locking mechanism

Position the test sample of a prosthetic knee unit as shown in Figures D.4 and D.5, i.e.

— with its axis of rotation (or reference axis) horizontal,

— with the long axis of the assembly inclined at β = 40° to the horizontal,

— with the frontal face of the assembly pointing upwards, and

— with the heel of the prosthetic ankle-foot device (see NOTE 4 of D.3.2) or the distal end of the sample resting on a horizontal surface in a manner providing low friction.

Support the proximal end of the sample in a pin joint.

Apply the operating force F_op to the actuator of the test sample in accordance with D.6.1.

Increase the operating force F_op at a rate not exceeding 10 N/s until the locking mechanism disengages.

NOTE 1 The disengagement of the locking mechanism may be tested manually by attempting to flex the joint.

Record the value of operating force, F_op1 at which the locking mechanism disengages, together with the value of the distance, d₁, of the line of action of F_op1 from the axis of the actuating lever (if present – see Figure D.5) at the instant of disengagement, if appropriate (see NOTE 1 of D.6.1).

Relock the knee joint and repeat the test procedure five times.

Calculate the mean of the values of operating force F_op1 measured in the six tests.

Repeat the six tests with a vertical force F_m applied to the distal segment of the test sample at a distance c ⩾ 50 mm from the knee axis of rotation (or reference axis) as illustrated in Figures D.4 and D.5 and specified in Table D.2 for the relevant test set-up.

NOTE 2 The vertical force F_m is applied to the test sample to simulate the effect of the user either inclining his/her trunk anteriorly while standing on the prosthetic device or applying a force manually to the front of the prosthetic device, or extending their hip, all of which will create a knee extension moment.

NOTE 3 To ensure that the vertical test force F_m applied produces a uniform effect, the value(s) of the distance “c” and/or the vertical force F_m need to be adapted to test set-ups with segmental lengths of the test sample differing from a = b = 450 mm and/or with a knee unit extending by more than 50 mm distal to the knee axis of rotation (or reference axis).

Record the value of operating force, F_op2 at which the locking mechanism disengages, together with the value of the distance, d₂, of the line of action of F_op2 from the axis of the actuating lever (if present) at the instant of disengagement, if appropriate (see NOTE 1 of D.6.1).

Calculate the mean of the values of operating force, F_op2 measured in the six tests.

Carry out the entire test procedure on a second test sample.

Calculate and record as the final test result the mean of the values of operating force, F_op measured in both test series.

NOTE 5 For specific designs of prosthetic knee unit it may also be of interest to establish the operating force required to engage the locking mechanism. For such designs the procedure of D.6.4 may be adapted for this purpose.

Table D.2 — Parameters of the test set-up for sample category D.3.1 c)

Test set-up	Segmental lengths of test sample		Distance of load application point from knee axis	Vertical force
Test set-up	a mm	b mm	c mm	F_m N
Regular	450	450	50	120
Individual	a_i	b_i	c_i > 50	F_mi = 24 × 10³(a_i + b_i)/a_i(b_i − c_i)

- 1. Test set-up for sample category: Prosthetic elbow units with locking mechanism

Position the test sample of a prosthetic elbow unit with the upper arm components vertical and the lower arm components locked horizontally (see Figure D.6). If the design of the test sample does not allow these positions to be achieved in one test set-up, set the lower arm components horizontal and the upper arm components as close as possible to the vertical.

Ensure that there is no other support for the elbow unit or the lower arm components.

Apply the operating force, F_op to the actuator of the test sample in accordance with D.6.1.

Increase the operating force, F_op at a rate not exceeding 10 N/s until the locking mechanism disengages.

Record the value of operating force, F_op1 at which the locking mechanism disengages, together with the value of the distance, d₁, of the line of action of F_op1 from the axis of the actuating lever (if present – see NOTE 1) at the instant of disengagement, if appropriate (see NOTE 1 of D.6.1).

NOTE 1 The operation of the type of locking mechanism on the sample of prosthetic elbow unit shown in Figure D.6 does not require an actuating lever.

Relock the elbow unit and repeat the test procedure five times.

Calculate the mean of the values of operating force F_op1 measured in the six tests.

Carry out the entire test procedure on a second test sample.

Calculate and record, as the final test result, the mean of the values of operating force F_op measured in both test series.

NOTE 2 If appropriate, the six tests can be repeated with a vertical force F_m applied to the test sample to represent either the weight of an article carried by a terminal device or any distally applied force considered to be representative of a typical situation in daily use. In the first case the same procedures as specified in D.6.3 for test samples of orthotic elbow joints can be applied; in the second case these procedures can be adapted accordingly.

NOTE 3 For specific designs of prosthetic elbow units it may also be of interest to establish the operating force required to engage the locking mechanism. For such designs the procedure of D.6.5 can be adapted for this purpose.

- 1. Test set-up for sample category: Prosthetic elbow units with user-driven articulation

Set the lower arm of the test sample of a prosthetic elbow unit to a length of f = 250 mm when measured from the elbow joint's pivot to the adaptor surface of the terminal device. Prepare the terminal device so that it grips a rod of 40 mm diameter with its “fingers” clasping the rod as far as possible. Cut the rod so that the sum of its mass and that of the terminal device is 500 g.

If the terminal device itself has a mass of 500 g or more, prepare it without a rod and with its “fingers” “closed”. Record the mass of the terminal device.

Position the unlocked test sample of prosthetic elbow unit with the upper arm components affixed vertically and the lower arm components placed horizontally on a support arranged at their distal end as illustrated in Figure D.7.

Place the upper end of a sheet of paper between the lower arm and its support and fix to its lower end a mass of 100 g approximately.

Apply the operating force F_op to the actuator of the test sample in accordance with D.6.1.

Increase the operating force F_op either in a continuous manner at a rate of 5 N/s or in increments of 5 N until the lower arm component lifts off the support, indicated by slipping of the sheet of paper.

Record the value of operating force F_op1 at which this occurs.

Re-arrange the test set-up and repeat the test procedure five times.

Calculate the mean of the values of operating force F_op1 measured in the six tests.

Carry out the entire test procedure on a second test sample.

Calculate and record as the final test result the mean of the values of operating force F_op measured in both test series.

- 1. Test set-up for sample category: Prosthetic terminal devices with built-in closing function

NOTE 1 This most common group of terminal devices incorporates mechanisms that provide, in their non-operated state, a “built-in” grip force of pre-determined magnitude, by means of preloaded internal spring elements, and that are opened by the application of an external operating force.

Position the test sample of a prosthetic terminal device as illustrated in Figure D.8, i.e.

— with the “fingers” pointing downwards, and

— with the contact area between the “finger tips” vertical, when gripping a thin article as for example a stiff sheet of 1 mm thickness.

Place the upper end of a sheet of paper between the “finger-tips” of the device and fix to its lower end a mass of 100 g approximately.

Apply the operating force F_op to the actuator of the test sample in accordance with D.6.1.

Increase the operating force, F_op either in a continuous manner at a rate of 1 N/s or in increments of 1 N until the terminal device opens at the “finger-tips”, indicated by slipping of the sheet of paper.

Record the minimum value of operating force, F_op1 at which this occurs, together with the value of the distance, d₁, of the line of action of F_op1 from the axis of the actuating lever (if present) at the instant of disengagement, if appropriate (see NOTE 1 of D.6.1).

Increase the opening movement of the terminal device either in a continuous manner at a speed of 1 mm/s or in increments of 1 mm until the maximum opening width/(grip width) is reached and record the related operating force F_op continuously or step-by-step.

NOTE 2 This method of operating the terminal device requires the test equipment used to be switched over from force control to displacement control.

Record the maximum value of operating force, F_op2 reached and the opening width at which this occurs (see NOTE 2), together with the value of the distance, d₂, of the line of action of F_op2 from the axis of the actuating lever (if present) at the instant of disengagement, if appropriate (see NOTE 1 of D.6.1).

NOTE 3 The maximum value of operating force, F_op may not occur at the maximum opening width.

Re-arrange the test set-up and repeat the test procedure five times.

Calculate the mean of the values of operating force, F_op1 and F_op2 measured in the six tests.

Carry out the entire test procedure on a second test sample.

Calculate and record as the final test result the mean of the values of operating force, F_op measured in both test series.

- 1. Test set-up for sample category: Prosthetic terminal devices with built-in opening function

NOTE This less common group of terminal devices incorporates mechanisms which provide a “built-in” opening force by means of preloaded internal spring elements, and which are closed by the application of an external operating force.

Position the test sample of a prosthetic terminal device with the “fingers” pointing downwards, as illustrated in Figure D.9.

Place a force transducer of a thickness of (25 ± 2) mm between the finger-tips so that the centroids of their areas of contact with the active surfaces of the force transducer are located on its measuring axis.

Apply the operating force F_op to the actuator of the test sample in accordance with D.6.1.

Increase the operating force, F_op either in a continuous manner at a rate of 1 N/s or in increments of 1 N until a grip force of 20 N is reached.

Record the value of operating force F_op1 at which this occurs, together with the value of the distance, d₁, of the line of action of F_op1 from the axis of the actuating lever (if present) at the instant of disengagement, if appropriate (see NOTE 1 of D.6.1).

Re-arrange the test set-up and repeat the test procedure five times.

Calculate the mean of the values of operating force, F_op1 measured in the six tests.

Carry out the entire test procedure on a second test sample.

Calculate and record, as the final test result, the mean of the values of operating force F_op measured in both test series.

- 1. Test set-up for sample category: Prosthetic terminal devices with no built-in closing or opening function, actuated by force application

Position the test sample of a prosthetic terminal device with the “fingers” pointing downwards, as illustrated in Figure D.10.

Apply the operating force, F_op to the actuator of the test sample in accordance with D.6.1.

Increase the operating force, F_op either in a continuous manner at a rate of 1 N/s or in increments of 1 N until a grip force of 20 N is reached.

Record the value of operating force, F_op1 at which this occurs, together with the value of the distance, d₁ of the line of action of F_op1 from the axis of the actuating lever (if present) at the instant of disengagement, if appropriate (see NOTE 1 of D.6.1).

Re-arrange the test set-up and repeat the test procedure five times.

Calculate the mean of the values of operating force, F_op1 measured in the six tests.

Carry out the entire test procedure on a second test sample.

Calculate and record as the final test result the mean of the values of operating force, F_op measured in both test series.

- 1. Test set-up for sample category: Prosthetic terminal devices with no built-in closing or opening support, actuated by torque application (rotation of the forearm relative to the socket)

Position the test sample of a prosthetic terminal device with the “fingers” pointing downwards, as illustrated in Figure D.11.

Apply the operating moment, M_op to the actuator of the test sample in accordance with D.6.1.

Increase the operating moment, M_op either in a continuous manner at a rate of 0,1 N^.m/s or in increments of 0,1 N^.m until a grip force of 20 N is reached.

Record the value of operating moment, M_op at which this occurs.

Re-arrange the test set-up and repeat the test procedure five times.

Calculate the mean of the values of operating moment, M_op measured in the six tests.

Carry out the entire test procedure on a second test sample.

Calculate and record as the final test result the mean of the values of operating moment, M_op measured in both test series.

- 1. Test set-up for sample category: Prosthetic terminal devices with break-open feature for emergency situations

Position the test sample of a prosthetic terminal device as illustrated in Figure D.12, i.e.

— with the axis of its adaptor vertical, and

— with the “fingers” pointing downwards.

Prepare the terminal device so that it grips a rod of 40 mm diameter with its “fingers” clasping the rod as far as possible.

Connect the rod to the distal end attachment without changing its position inside the terminal device.

If appropriate, incorporate a force transducer in the distal end attachment assembly in accordance with D.3.2, as illustrated in Figure D.12.

NOTE If the force transducer is mounted in a manner differing from that shown in Figure D.12, it can be subject to offset force. In this circumstance it will be crucial to establish that it will give accurate readings.

Apply the tensile force, F to the proximal end of the test sample in accordance with D.6.1.

Increase the tensile force, F either in a continuous manner at a rate of 5 N/s or in increments of 5 N until the break-open mechanism operates, so that the “fingers” open and the rod slips out of the terminal device.

Record the maximum value of tensile force, F_max reached.

Re-set the terminal device to its normal operating configuration.

Re-arrange the test set-up and repeat the test procedure five times.

Calculate the mean of the values of tensile force, F_max measured in the six tests.

Carry out the entire test procedure on a second test sample.

Calculate and record as the final test result the mean of the values of tensile force, F_max measured in both test series.

- 1. Test set-up for sample category: Prosthetic devices with fail-safe release units

Position the test sample of a prosthetic device with its axis vertical, as illustrated in Figure D.13 for the example of a separable prosthetic adaptor plate.

If appropriate, incorporate a force transducer in the distal end attachment assembly in accordance with D.3.2, as illustrated in Figure D.13.

NOTE 1 If the force transducer is mounted in a manner differing from that shown in Figure D.13, it may be subject to offset force. In this circumstance it will be crucial to establish that it will give accurate readings.

Apply the tensile force, F to the proximal end of the test sample in accordance with D.6.1.

NOTE 2 Several trials can be necessary to establish the most appropriate details of the test procedure.

Increase the tensile force, F either in a continuous manner at a rate of 5 N/s or in increments of 5 N until the fail-safe release unit operates and the adjacent components disconnect.

Record the maximum value of tensile force F_max reached.

Re-set the prosthetic device to its normal operating configuration.

Re-arrange the test set-up and repeat the test procedure five times.

Calculate the mean of the values of tensile force, F_max measured in the six tests.

Carry out the entire test procedure on a second test sample.

Calculate and record as the final test result the mean of the values of tensile force, F_max measured in both test series.

1. Test report
  1. General

For each type of test conducted, the test report should specifically refer to Annex D and state the relevant category of test sample according to Clause D.3 and the relevant test set-up according to Clause D.6.

- 1. Specific requirements

The details which shall be included in the test report are listed in Table D.3, together with the relevant test set-ups according to Clause D.6.

Table D.3 — Details of the test report

Item			Relevant test set-up
a)	Details of the test sample
	1)	List of the components of which the assembly is composed	All
	2)	Dimensions a, b or f of single segments of the test sample	D.6.2, D.6.4 or D.6.6
	3)	Mass of terminal devices m ⩾ 500 g	D.6.6
b)	Details of the test set-up
	1)	Direction of the line of action of the operating force F_op (tensile force F)	All, except D.6.10
	2)	Distance e of a remote actuator (if present) from the knee (reference) axis	D.6.4
	3)	Value(s) of the vertical force F_m representing the weight of body parts	D.6.4
	4)	Distance c of the vertical force F_m from the knee (reference) axis	D.6.4
	5)	Direction of the line of action (orientation) of the operating moment M_op	D.6.10
c)	Results of measurements and calculations
	1)	Individual values of the operating force F_op	All, except D.6.11, D.6.12
	2)	Calculated mean value(s) of operating force F_{op, mean}	All, except D.6.11, D.6.12
	3)	Individual values of the distance d of the line of action of the operating force F_op from the axis of an actuating lever (if present)	D.6.2, D.6.3, D.6.4, D.6.5, D.6.7, D.6.8, D.6.9
	4)	Individual values of the operating moment M_op	D.6.10
	5)	Calculated mean value of operating moment M_{op, mean}	D.6.10
	6)	Individual values of the tensile force F	D.6.11, D.6.12
	7)	Calculated mean value of tensile force F_mean	D.6.11, D.6.12

1. Test results

NOTE The test methods specified in Clause D.6 have been applied by several laboratories to the control and actuating mechanisms of a selection of state-of-the-art prosthetic and orthotic devices, including samples of all categories specified in D.3.1 except category D.3.1 k). In Table D.4 the ranges of operating force (and displacement) or moment which have been measured are listed for each category of test sample.

Table D.4 — Values of actuating/operating force (and displacement) and moment measured on different categories of test sample

Category of test sample	Number of samples of different types tested	Operating force (and displacement) or moment required for action/event indicated
Category of test sample	Number of samples of different types tested	Type of operating force or moment	Action/event	Range/value of force (N)	Range/value of moment (N^.m)	Range/value of displacement (mm)
Orthotic knee joints with locking mechanism — D.3.1 a)	25	Release force	Unlocking	2 to 65		—
Orthotic elbow joints with locking mechanism — D.3.1 b)	1	Release force	Unlocking	25		—
Prosthetic knee units with locking mechanism — D.3.1 c)	8	Release force	Unlocking	20 to 35		—
Prosthetic elbow units with locking mechanism — D.3.1 d)	7	Locking force ^a	Locking ^a	12 to 39		3 to 14
	14	Release force	Unlocking	6 to 45		2 to 30
Prosthetic elbow units with user-driven articulation — D.3.1 e)	5	Lifting force at 90°	Elbow flexion (paper slips)	15 to 48		—
Prosthetic terminal devices with built-in closing function — D.3.1 f)	30	Opening force	Fingers opening (paper slips)	4 to 78		—
	55	Opening force	Max. opening	4 to 194		32 to 52
Prosthetic terminal devices with built-in opening function — D.3.1 g)	5	Closing force	20 N grip force at 25 mm grip width	43 to 136		—
Prosthetic terminal devices with no built-in function, force-operated — D.3.1 h)	3	Closing force	20 N grip force at 25 mm grip width	56 to 67		—
Prosthetic terminal devices with no built-in function, torque-operated — D.3.1 i)	4	Closing moment	20 N grip force at 25 mm grip width		0,6 to 0,8	—
Prosthetic terminal devices with emergency break-open feature — D.3.1 j)	1	Break-open force	Breaking free	134		—
Prosthetic devices with fail-safe release function — D.3.1 k)	—	Fail-safe release force	Fail-safe release	—		—

^a See NOTE 3 of D.6.5.

Key

1 bowden cable with double 180° bend (or S-bend)

Figure D.1 — Bowden cable arrangement during test

Key

1 bale lock

F_op operating force

F_m vertical force

a distance from proximal end joint axis to knee axis

b distance from knee centre to center of distal end of the assembly

c distance from knee axis to vertical force application point

d distance of line of action of operating force to the axis of actuation lever beta inclination of longitudinal axis of the assembly relative to the horizontal

Figure D.2 — Test set-up according to D.6.2 for sample category D.3.1 a) Orthotic knee joints with locking mechanism

Key

1 drop or ring lock

F_op operating force

F_m vertical force

Figure D.3 — Test set-up according to D.6.3 for sample category D.3.1 b) Orthotic elbow joints with locking mechanism

Key

1 remote actuator

F_op operating force

F_m vertical force

a distance from proximal end joint axis to knee axis

b distance from knee axis to foot sole

c distance from knee axis to vertical force application point

d distance of line of action of operating force to the axis of actuating lever of remote actuator

e distance between knee axis and locking mechanism rotation point

Figure D.4 — Test set-up according to D.6.4 for sample category D.3.1 c) Prosthetic knee units with locking mechanism
(continued on Figure D.5)

Key

1 bale lock

F_op operating force

F_m vertical force

Figure D.5 — Test set-up according to D.6.4 for sample category D.3.1 c) Prosthetic knee units with locking mechanism
(continued from Figure D.4)

Key

1 toggle release mechanism

F_op operating force (acting parallel to adaptor axis unless otherwise specified by manufacturer)

Figure D.6 — Test set-up according to D.6.5 for sample category D.3.1 d) Prosthetic elbow units with locking mechanism

Key

1 rod

2 support

3 sheet of paper

4 100 g mass

f distance from the elbow axis of rotation to the wrist joint

D diameter of rod

F_op operating force (acting parallel to adaptor axis unless otherwise specified by manufacturer)

Figure D.7 — Test set-up according to D.6.6 for sample category D.3.1 e) Prosthetic elbow units with user-driven articulation

Key

1 pivot

2 contact area vertical

3 sheet of paper

4 100 g mass

F_op operating force (acting parallel to adaptor axis unless otherwise specified by manufacturer)

Figure D.8 — Test set-up according to D.6.7 for sample category D.3.1 f) Terminal devices with built-in closing function

Key

1 pivot

2 centroids of contact areas

3 measuring axis of force transducer

F_op operating force (acting parallel to adaptor axis unless otherwise specified by manufacturer)

Figure D.9 — Test set-up according to D.6.8 for sample category D.3.1 g) Terminal devices with built-in opening function

Key

1 pivot

2 centroids of contact areas

3 measuring axis of force transducer

F_op operating force (acting parallel to adaptor axis unless otherwise specified by manufacturer)

Figure D.10 — Test set-up according to D.6.9 for sample category D.3.1 h) Terminal devices with no built-in closing or opening function, actuated by force application

Key

1 pivot

2 centroids of contact areas

3 measuring axis of force transducer

M_op operating moment (acting about its axis of rotation unless otherwise specified by manufacturer)

Figure D.11 — Test set-up according to D.6.10 for sample category D.3.1 i) Terminal devices with no built-in closing or opening function, actuated by torque application

Key

1 rod of 40 mm diameter

2 measuring axis of force transducer (initially aligned with adaptor axis, if appropriate)

3 force transducer

F tensile force (acting along measuring axis of force transducer)

Figure D.12 — Test set-up according to D.6.11 for sample category D.3.1 j) Terminal devices with break-open feature for emergency situations

Key

1 prosthetic device under test

2 measuring axis of force transducer (initially aligned with adaptor axis, if appropriate)

3 force transducer

F tensile force (acting along measuring axis of force transducer)

Figure D.13 — Test set-up according to D.6.12 for sample category D.3.1 k) Prosthetic devices with fail-safe release unit, illustrated for a separable prosthetic adaptor plate

(informative)

Reference to the essential principles of safety and performance of medical devices in accordance with ISO/TR 16142

This document supports the essential principles of safety and performance of external limb prostheses and external orthoses as medical devices in accordance with ISO/TR 16142. This document is suitable for conformity assessment purposes.

Conformity with this document provides one means of demonstrating conformity with specific essential principles of ISO/TR 16142. Other means are possible.

NOTE 1 The essential principles of safety and performance according to ISO/TR 16142 conform, in both structure and contents, to the essential requirements according to Annex I of the European Directive 93/42/EEC concerning medical devices with a few exceptions.

Table E.1 lists the correspondence between this document and the essential principles of ISO/TR 16142.

Table E.1 — Correspondence between this document and the essential principles of ISO/TR 16142

Clauses/sub-clauses of this document	Corresponding essential principle of ISO/TR 16142:1999	Qualifying remarks/notes
All	A.1
All and specifically: 4.1, 5.1, 5.4, 7, 8.2, 8.3, 9, 11.1, 11.2	A.2	Specifically: risk management, flammability/toxicity, corrosion/degradation, EMC, battery-powered devices, surface temperature, moving parts, connections
All and specifically 4.2	A.3	Specifically: intended performance
All and specifically 4.2, 4.4	A.4	Specifically: intended performance, strength
All and specifically 13, 14	A.5	Specifically: information, packaging
All and specifically 4.1	A.6	Specifically: risk management
5.1, 5.2	A.7.1	Flammability/toxicity, biocompatibility/contaminants/ residues
5.2, 13, 14	A.7.2	Biocompatibility/contaminants/residues, information, packaging
5.2.2, 5.4	A.7.3	Contaminants/residues, corrosion/degradation
5.2, 5.4, 10.2	A.7.6	Biocompatibility/contaminants/residues, corrosion/ degradation, connections
5.2, 5.3	A.8.1	Biocompatibility/contaminants/residues, infection and microbiological contamination
14	A.8.5	Packaging
12.1, 13	A.9.1	Restrictions on use, information
7, 9, 11.1, 12.2,12.3	A.9.2	EMC, surface temperature, moving parts, forces on soft tissues of the human body, ergonomic principles
5.1, 8.2, 8.4	A.9.3	Flammability/toxicity, battery-powered devices
8.3	A.12.1	Electronic programmable systems
8.1, 8.2	A.12.2	Battery-powered devices
7	A.12.5	EMC
8	A.12.6	Electrical safety
11, 12	A.12.7.1	Design and mechanical requirements
6	A.12.7.2	Vibration
6	A.12.7.2	Noise
8.2, 11.2	A.12.7.3	Battery-powered devices, connections
9	A.12.7.4	Surface temperature
8.5	A.12.8.2	Skin contact electrodes stimulate by means of electrical energy and may be considered as energy supply in the sense of ER 12.8
13.1, 13.2	A.12.8.3	Information
13	A.13	Information, packaging
10	A.13	Information on sterilization if specific devices require to be sterilized for particular applications
4.3	A.14	Clinical evaluation

Symbols specifying the environmental conditions that prosthetic or orthotic components can withstand

This International Standard supports the use of standardized symbols to describe the environmental conditions that prosthetic or orthotic components can withstand. The symbols are reported in Table F.1 (column B), along with the environmental conditions they describe (column C), and examples of the environmental conditions to which the symbols apply (column D).

When presented, all six symbols shall appear together. Examples of correct use are reported in Figure F.1.

When an environmental condition is not applicable to a component, it should be crossed out with a circle and diagonal bar.

When symbols F.1-F.3 are not crossed out, they shall report the maximum allowed depth for submersion, expressed in meter. The actual number of meters can vary, depending on the risk analysis completed by the manufacturer, and shall be specified by replacing the “X m” text under symbols F.1-F.3 with the actual value.

For prosthetic components, the symbols shall be included in instructions for use, and they should be included in catalogues, brochures, marketing materials, and other product advertisements.

For orthotics components, the use of the symbols is suggested. The symbols are not required on the component or component data label.

Table F.1 — Symbols to describe the environmental conditions that prosthetic or orthotic components can withstand

A . Symbol ID	B. Symbol	C. Description of the condition	D. Example of environmental conditions
F.1		The component can be used for submersion in salt water up to a depth of X m	Sea Saltwater pools
F.2		The component can be used for submersion in chlorine water up to a depth of X m	Pool with chlorine water SPA
F.3		The component can be used for submersion in fresh water, such as a lake or a river, up to a depth of X m	Lake River
F.4		The component can be used to take a shower in soapy water.	Shower with soap
F.5		The component can be exposed to wet weather conditions.	Rain Falling snow
F.6		Please refer to the instruction for use for details about the maximum exposure time to the different environmental conditions

Figure F.1 — Examples of correct use of the symbols reported in Table F.1

Annex ZA
(informative)

Relationship between this European standard and
the General Safety and Performance Requirements of
Regulation (EU) 2017/745 aimed to be covered

This European standard has been prepared under M/575 to provide one voluntary means of conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117] and to system or process requirements including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up.

Once this standard is cited in the Official Journal of the European Union under that Regulation, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding General Safety and Performance Requirements of that Regulation, and associated EFTA Regulations.

Where a definition in this standard differs from a definition of the same term set out in Regulation (EU) 2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this Regulation prevail.

Where the European standard is an adoption of an International Standard, the scope of this standard can differ from the scope of the European Regulation that it supports. As the scope of the applicable regulatory requirements differ from nation to nation and region to region, the standard can only support European regulatory requirements to the extent of the scope of the European regulation for medical devices (EU) 2017/745).

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be ‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance Requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.

NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard.

Table ZA.1 — Correspondence between this European standard and Annex I of Regulation (EU) 2017/745 [OJ L 117] and to system or process requirements including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up

General Safety and Performance Requirements of Regulation (EU) 2017/745	Clause(s) / sub-clause(s) of this EN	Remarks / Notes
4	9	Surface temperature
6	4.2, 4.4	Intended performance, strength
7	12	Information
8	4.1	Specifically: Risk management
10.1	5.1, 5.2	Flammability/toxicity, biocompatibility/contaminants/residues
10.2	5.2, 12	Biocompatibility/contaminants/residues, information
10.3	5.2.2, 5.4	Contaminants/residues, corrosion/degradation
10.5	5.2, 5.4, 10.2	Biocompatibility/contaminants/residues, corrosion/ degradation, connections
11.1	5.2, 5.3	Biocompatibility/contaminants/residues, infection and microbiological contamination
14.1	11.1, 12	Restrictions on use, information
14.2 b)	9, 10.1, 11.2	Specially: Surface temperature, moving parts, forces on soft tissues on the human body
14.3	5.1, 8.2, 8.4	Inflammability/toxicity, battery powered devices
17.1	8.3	Electronic programmable systems
18.2	8.1, 8.2	Battery-powered devices
18.7	8	Electrical safety
20.1	10, 11	Design and mechanical requirements
20.4	8.2	Battery-powered devices, power supply
20.6	9	Surface temperature
21.2	8.5	Skin contact electrodes stimulate by means of electrical energy and may be considered as energy supply in the sense of GSPR 21.2
21.3	12.1, 12.2	Information
23.2 m	12	Information

WARNING 1: Presumption of conformity stays valid only as long as a reference to this European standard is maintained in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union.

WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this standard.

Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this Annex ZA

Column 1 Reference in Clause 2	Column 2 International Standard Edition	Column 3 Title	Column 4 Corresponding European Standard Edition
ISO 10328	ISO 10328:2016	Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods	EN ISO 10328:2016
ISO 14155	ISO 14155:2020	Clinical investigation of medical devices for human subjects — Good clinical practice	EN ISO 14155:2020
ISO 15032	ISO 15032:2000	Prosthetics — Structural testing of hip units	None For applicable standard edition see Column 2
ISO 20417:2021	ISO 20417:2021	Medical devices — Information to be provided by the manufacturer	EN ISO 20417:2021
ISO 22675	ISO 22675:2016	Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods	EN ISO 22675:2016
IEC 60601-1	IEC 60601-1:2005 + Cor1:2006 + Cor2:2007 + A1:2012 + A1:2012/Cor1:2014 + A2:2020	Medical electrical equipment — Part 1: General requirements for safety	EN 60601-1:2006 + Cor.:2010 + A1:2013 + AC:2014 + A1:2013/AC:2014 + A12:2014 + A2:2021
IEC 60601-1-2	IEC 60601-1-2:2014 + A1:2020	Medical electrical equipment — Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests	EN 60601-1-2:2015 + A1:2021

The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in this document, i.e. are indispensable for its application. The achievement of the presumption of conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.

WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European standard is maintained in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union.

WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of this standard.

Bibliography

[1] ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes

[2] ISO 14971, Medical devices — Application of risk management to medical devices

[3] ISO 8191, Furniture — Assessment of ignitability of upholstered furniture — Part 1: Ignition source: smouldering cigarette

[4] ISO 10993‑1, Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

[5] ISO 24562, Prosthetics — Geometrical aspects of lower limb prosthetic adapters

[6] IEC 62304, Medical device software — Software life cycle processes

[7] IEC 62366‑1, Medical devices — Part 1: Application of usability engineering to medical devices

[8] IEC 60601‑1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

[9] IEC 60601‑1-11, Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

[10] IEC 80601‑2-35, Medical electrical equipment — Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

[11] ISO 9227, Corrosion tests in artificial atmospheres — Salt spray tests

[12] ASTM G85, Standard Practice for Modified Salt Spray (Fog) Testing

[13] ASTM B117, Standard Practice for Operating Salt Spray (Fog) Apparatus

[14] ISO 13405‑3, Prosthetics and orthotics — Classification and description of prosthetic components — Part 3: Description of upper limb prosthetic components

[15] IMDRF MDCE WG/N56FINAL:2019

Table of Contents

1.0 Scope

2.0 Normative references

3.0 Terms and definitions

4.0 General requirements

4.1 Risk management

4.1.1 Intended performance and technical documentation

4.1.2 Clinical evaluation

4.1.3 Strength and related conditions of use

5.0 Requirements for materials

5.1 Flammability of materials and toxicity of combustion products

5.1.1 Biocompatibility, contaminants and residues

5.1.2 General

5.1.3 Contaminants and residues

5.2 Infection and microbial contamination

5.2.1 Resistance to corrosion and degradation

6.0 Noise and vibration

7.0 Electromagnetic compatibility (EMC)

8.0 Electrical safety

8.1 Battery-powered prosthetic and orthotic devices

8.1.1 Battery housings and connections

8.1.2 Charge level indicators

8.2 Circuit protection

8.2.1 Electronic programmable systems

8.2.2 Electrically heated blankets, pads and similar flexible heating appliances

8.2.3 Prosthetic and orthotic devices with skin contact electrodes

8.2.4 Prosthetic and orthotic devices with radio equipment

8.2.5 General

8.2.6 Frequency spectrum of radio equipment

8.2.7 Operation of radio equipment by the user

9.0 Surface temperature

10.0 Design requirements

10.1 Safety of moving parts

10.1.1 Safety of connections

11.0 Mechanical requirements

11.1 Restrictions on use

11.1.1 Forces in soft tissues of the human body

11.1.2 Ergonomic principles

12.0 Information supplied by the manufacturer

12.1 General

12.1.1 Labelling

12.1.2 Intended use

13.0 Packaging