ISO/DIS 3826-3:2026(en)
Secretariat: DIN
ISO/TC 76
Date: 2025-12-16
Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems and its integrated features
Poches en plastique souple pour le sang et les composants du sang — Partie 3: Systèmes de poches pour le sang avec accessoires intégrés
Kunststoffbeutel für menschliches Blut und Blutbestandteile — Teil 3: Blutbeutelsysteme mit integrierten Merkmalen
© ISO 2026
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Contents Page
Foreword v
Introduction vii
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Dimensions and examples 2
5 Design 5
5.1 Leucocyte filter 5
5.2 Pre-donation sampling device 5
5.3 Top-and-bottom bag and top-and-top bag 5
5.4 Platelet storage bag 6
5.5 Needle stick protection device 6
5.6 Air content 6
6 Requirements 6
7 Packaging 7
8 Labelling 8
9 Anticoagulant and/or preservative solution 9
Annex ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered 10
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 3826-3:2008), which has been technically revised.
The main changes compared to the previous edition are as follows:
— Title has changed from “… with integrated features” to “… and its integrated features”;
— the term “top-and-top bag” has been added and considered throughout the whole document;
— the designation example has been removed;
— Table 1 has been amended with the sub-entries of 6.5.2 in alignment with ISO 3826-1:2019/Amd 1:2023;
— Clause 7 has been reduced to one descriptive sentence;
— Table 2, column “Requirements” has been aligned with ISO 3826-1:2019;
— update of normative references;
— complete editorial revision.
A list of all parts in the ISO 3826 series can be found on the ISO website.
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.
Introduction
The manufacturers or suppliers of the plastic containers are expected to disclose in confidence to the national control authority, if requested by them, full details of the plastic material(s) and the components of the materials and their methods of manufacture, details of the manufacture of the plastic containers including the chemical names and quantities of any additives, whether incorporated by the manufacturer of the plastic containers or present in the raw material, as well as full details of any additives that have been used.
Plastics collapsible containers for human blood and blood components —INTERNATIONAL STANDARD© ISO 2006 – All rights reservedISO 3826-3:2006(E) 54Part 3: Blood bag systems with integrated featuresPlastics collapsible containers for human blood and blood componentsPoches en plastique souple pour le sang et les composants du sang — Partie 3: Systèmes de poches pour le sang avec accessoires intégrésPlastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated featuresE2006-04-26(60) PublicationISOISO International Standard 2006ISO 3826‑ISO 3826‑3ISO 3826-3 DIN Transfusion, infusion and injection equipment for medical and pharmaceutical use 76 2Heading 2Heading 1 0 CR6STD Version 2.260 4O:\Documents\TC076\038795 - ISO 3826-3 (Ed 1)\60.00\310\038795e\C038795e.doc Part 3: Blood bag systems and its integrated features
1.0 Scope
This document specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). Blood bag systems need not contain all of the integrated features identified in this document.
The integrated features refer to:
— leucocyte filter;
— pre-donation sampling device;
— top-and-bottom bag;
— platelet storage bag;
— needle stick protection device.
In addition to ISO 3826-1, which specifies the requirements of conventional containers, this document specifies additional requirements for blood bag systems using multiple units. This document does not cover automated blood collection systems.
Unless otherwise specified, all tests specified in this document apply to the plastic container as prepared ready for use.
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 3826‑1:2019[1], Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers
3.0 Terms and definitions
For the purposes of this document, the terms and definitions 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
leucocyte filter
LCF
filter used to reduce the content of leucocytes in blood or blood components
3.2
pre-donation sampling device
PDS
device integrated in the donor line of blood bag systems and designed to separate the first volume of donated blood
Note 1 to entry: The pre-donation sampling device is integrated in the donor line through a Y-piece, such that blood may only flow into the pre-donation sampling device or into the blood bag.
3.3.1
top-and-bottom bag
TBB
bag containing top-and-bottom inlets and outlets
Note 1 to entry: The top-and-bottom bag is part of a multiple bag system and is designed to allow centrifugation of anticoagulated whole blood. After centrifugation the plasma is separated through the top and red cell concentrate through the bottom outlet of the bag.
3.3.2
top-and-top bag
TTB
bag containing top inlets and outlets
Note 1 to entry: The top-and-top bag is part of a multiple bag system and is designed to allow centrifugation of anticoagulated whole blood. After centrifugation the plasma is separated through the top outlet and red cell concentrate will be kept in the bag.
3.4
platelet storage bag
PSB
bag suitable for appropriate storage of a therapeutic dose of platelet concentrates, obtained from a single donation or a pool of donations
Note 1 to entry: The platelet storage bag can stand alone or be part of a blood bag system.
3.5
needle stick protection device
NPD
device integrated in the donor line of blood bag systems, containing the donor needle, and designed to prevent undesirable needle sticks after use of the donor needle
4.0 Dimensions and examples
Figure 1 and Figure 2 illustrate the components of a blood bag system with integrated features. The general drawings and the drawing of each feature are for guidance only. The dimensions shall be in accordance with those listed in ISO 3826-1:2019, Clause 4, Figure 1.
Plastics containers are designated using the descriptor words “Plastics container” followed by the number of this document, in turn followed by the abbreviation of the relevant integrated feature given in Clause 3. For example, the designation of a plastics container with a leucocyte filter in accordance with this document is:
Plastics container ISO 3826-3 – LCF.
Key
1 pre-donation sampling device (PDS)
2 pre-donation sampling bag
3 multiple sampling device
4 blood-taking needle
5 needle stick protection device (NPD)
6 blood bag system
7 top-and-bottom bag (TBB)
8 (top) outlet
9 bottom outlet
10 collection tube
11 transfer bags
12 empty transfer bag
13 platelet storage bag (PSB)
14 bottom empty transfer bag
15 transfer bag with additive solution
16 leucocyte filter (LCF)
a Means of closure. The means may be positioned at other sites.
b In the present configuration the TBB is the collection container and contains the anticoagulant. This component may also be a top-and-top bag (TTB, not shown in this Figure).
c In the present configuration the LCF is a red cell concentrate filter.
Figure 1 — Schematic representation of components of a blood bag system with integrated features — Top-and-bottom bag system with integrated red cell filter, platelet storage bag and
pre-donation sampling device
Key
1 pre-donation sampling device (PDS)
2 pre-donation sampling bag
3 multiple sampling device
4 blood-taking needle
5 needle stick protection device (NPD)
6 blood bag system
7 collection bag
8 outlet
9 collection tube
10 transfer bags
11 empty transfer bag
12 transfer bag with additive solution
13 leucocyte filter (LCF)
a Means of closure. The means may be positioned at other sites.
b In the present configuration the collection bag contains the anticoagulant.
c In the present configuration the LCF is a whole blood filter.
Figure 2 — Schematic representation of components of a blood bag system with integrated features — Quadruple blood bag system with integrated whole blood filter and
pre-donation sampling device
5.0 Design
5.1 Leucocyte filter
5.1.1 The leucocyte filter is integrated in plastic container(s) as a whole blood filter or a blood component filter. It is designed to reduce the leucocyte content of one whole blood unit or blood component unit. The filters may be designed to work by gravity or pressure filtration at 4 °C or ambient temperature, depending on required specifications.
Leucocyte filters may also be integrated in other transfusion equipment.
Leucocyte filters might be subject to national requirements and standards.
5.1.2 Manufacturers shall give recommendations for the intended use of the leucocyte filters considering parameters including:
— delay between blood collection and leucoreduction;
— capacity of the filter;
— blood filtration temperature;
— filtration height;
— use of pressure;
— suitability for centrifugation.
5.1.1 Pre-donation sampling device
5.2.1 The pre-donation sampling device shall permit the collection, under aseptic conditions, of a range of donor samples taken into evacuated sample tubes.
5.2.2 If the pre-donation sampling device includes a collection pouch, then its capacity shall be at least 35 ml.
5.2.3 The pre-donation sampling device shall be designed to be filled with a mean flow rate of at least 50 ml/min when tested in accordance with ISO 3826-1:2019, B.2.
5.2.4 Means shall be provided which prevent the return of blood and/or air from the sampling site towards the donor and donation after the filling of the pre-donation sampling device. The means may or may not be integrated.
For collection of specific samples, it may be necessary to avoid the presence of anticoagulant and haemolysis in the pre-donation sample.
5.2.5 Manufacturers shall give recommendations for the optimal use of the pre-donation sampling device.
5.1.2 Top-and-bottom bag and top-and-top bag
5.3.1 The top-and-bottom bag usually works with an automatic press system that allows the use of, for example, optical sensors and a residual volume between the top and bottom layer containing a large content of platelets and leucocytes (the buffy coat).
5.3.2 If tubes of top and bottom outlets have different dimensions, on request they shall be provided by the manufacturers.
5.3.3 The top-and-top bag works with a manual press system or an automatic press system that allows the use of optical sensors to detect and separate different layers, for example plasma and buffy coat.
5.1.3 Platelet storage bag
5.4.1 Platelet storage bags shall have good gas permeability for both oxygen and carbon dioxide and shall allow storage of platelet concentrates under temperature-controlled conditions for several days (under continuous agitation).
5.4.2 Platelet storability is also influenced by number of platelets, volume of platelet concentrate, size of the container and agitation and is usually assessed by observation of swirling and by measurement of pH, hypotonic shock response and aggregation.
5.1.4 Needle stick protection device
Manufacturers shall give recommendations for the optimal use of the needle stick protection device.
Note: Needle stick protection devices can be subject to national requirements and standards.
5.1.5 Air content
The air contained in a filter sub-assembly or pre-donation pouch need not be included in the air volume calculation, in accordance with ISO 3826-1:2019, 5.2, if by design or operation of the system such inherent air does not end up in the final collected blood component product.
The air volume limit requirement does apply to other containers, such as the top-and-bottom bag and the platelet bag, when they are utilized as final storage containers within the system.
6.0 Requirements
Table 1 provides an overview of the requirements given in ISO 3826-1:2019, Clause 6, related to each of the integrated features specified in this document.
Table 1 — Applicability to ISO 3826-1:2019, Clause 6, requirements, for blood bag systems and its integrated features
Requirements (clause and short name in accordance with ISO 3826-1:2019) | Leucocyte filter | Pre-donation sampling device | Top-and-bottom bag/ Top-and-top bag | Platelet storage bag | Needle stick protection device | |
|---|---|---|---|---|---|---|
6.1 | General | Yes a | Yes | Yes | Yes | Yes |
6.2 | Physical requirements | |||||
6.2.1 | Conditions of manufacture | Yes | Yes | Yes | Yes | Yes |
6.2.2 | Sterilization | |||||
6.2.2.1 | Sterilization method | Yes | Yes | Yes | Yes | Yes |
6.2.2.2 | Sterilization adverse affect | Yes | Yes | Yes | Yes | Yes |
6.2.2.3 | Sterilization effectiveness | Yes | Yes | Yes | Yes | No |
6.2.3 | Transparency | No | Yes | Yes | Yes | No |
6.2.4 | Coloration | No | Yes | Yes | Yes | No |
6.2.5 | Thermal stability | No | No | Yes | Yes | No |
6.2.5.1 | General | Yes | Yes | Yes | Yes | No |
6.2.5.2 | Freezing | No | No | No | Yes | No |
6.2.5.3 | Ionizing irradiation | No | No | Yes i | Yes | No |
6.2.6 | Water vapour transmission | No | No | Yes | No b | No |
6.2.7 | Resistance to leakage | Yes c | Yes d | Yes | Yes | No |
6.2.8 | Particulate contamination | Yes | Yes | Yes | Yes | No |
6.3 | Chemical requirements | |||||
6.3.1 | Requirements for the raw container or sheeting | No | Yes e | Yes | Yes | No |
6.3.2 | Requirements for the test fluid | No f | Yes e | Yes | Yes | No |
6.4 | Biological requirements | |||||
6.4.1 | General | Yes | Yes | Yes | Yes | No |
6.4.2 | Impermeability for micro-organisms | Yes g | Yes h | Yes | Yes | No |
6.4.3 | Compatibility | Yes | Yes | Yes | Yes | No |
a Leucocyte filters need not be flexible. b The permeability of the material shall be suitable for supporting viable platelets for the given storage time. See specific requirements for platelet storage bags. c Leucocyte filters shall be able to resist leakage under the maximum pressure exerted by normal working conditions depending on the filter type (i.e. gravity feed at maximum head height or plasma press). d Pre-donation sampling pouch shall be able to withstand pressure test except for centrifugation and 4 °C test. e Applies to container only. f The filter shall fulfil the requirements given in the relevant pharmacopoeias for physiochemical tests for plastics. g The leucocyte filter housing must be impermeable to micro-organisms. The filter is not intended to remove micro-organisms from blood or blood components. h Applies to the contents of the sample pouch only. The transfer tube above the pouch should be permanently sealed before attempting to remove blood through the sample site coupler. i For top-and-bottom bag: No / For top-and-top bag: Yes | ||||||
7.0 Packaging
The assessment of the packaging configuration shall be in accordance to ISO 3826-1:2019, Clause 7. This is applicable for packaging of all design aspects outlined in Clause 5 of this document.
8.0 Labelling
Table 2 provides an overview of the requirements given in ISO 3826-1:2019, Clause 8, related to each of the integrated features specified in this document.
Table 2 — Applicability to ISO 3826-1:2019, Clause 8, labelling, for blood bag systems and its
integrated features
Requirements (clause and short name in accordance | Leucocyte filter | Pre-donation sampling device | Top-and-bottom bag/ Top-and top bag | Platelet storage bag | Needle stick protection device | |
|---|---|---|---|---|---|---|
8.1 | General | Yes | Yes | Yes | Yes | Yes |
8.2 | Label on plastics container | |||||
8.2 a) | Manufacturer/supplier details | No | No | Yes | Yes | No |
8.2 b) | Contents and use | Optional | Optional | Yes | Yes | No |
8.2 c) | Anticoagulant/preservative formulation, collection volume | No | No | Yes | Yes | No |
8.2 d) | Statement on sterility and pyrogenicity | No | No | Yes | Yes | No |
8.2 e) | Lot designation | Optional | No | Yes | Yes | No |
8.2 f) | Single use instruction | No | No | Yes | Yes | No |
8.2 g) | Instructions on deterioration | No | No | Yes | Yes | No |
8.2 h) | Do not vent instruction | No | No | Yes | Yes | No |
8.2 i) | Reference to instructions for use | No | No | Yes | Yes | No |
8.3 | Label on over-package d | |||||
8.3 a) | Manufacturer/supplier details | Yes | ||||
8.3 b) | Description of contents | Yes a | Yes a | Yes | Yes | Yes a |
8.3 c) | Lot designation | Yes | ||||
8.3 d) | Expiry date | Yes | ||||
8.3 e) | Instructions on expiry after removal from over-package | Yes | ||||
8.4 | Label on shipping box | |||||
8.4 a) | Manufacturer/supplier details | Yes | ||||
8.4 b) | Description of contents | Yes | ||||
8.4 c) | Lot designation | Yes | ||||
8.4 d) | Expiry date | Yes | ||||
8.4 e) | Instructions on expiry after removal from over-package | Yes e | ||||
8.4 f) | Storage conditions | Yes | ||||
8.5 | Label requirements | |||||
8.5 a) | Area for information on manufacturer and use | Optional | Optional | Yes | Yes | No |
8.5 b) | Permit visual inspection of contents | Yes | Yes | Yes | Yes | No |
8.5 c) | Ensure print does not diffuse | Yes | Yes | Yes | Yes | N/A b |
8.5 d) | Label print legible at time of use | Yes | Yes | Yes | Yes | N/A b |
8.5 e) | Suitability of label adhesive | Yes | Yes | Yes | Yes | N/A b |
8.5 f) | Tamper evidence | Yes | Yes | Yes | Yes | N/A b |
8.5 g) | Shall pass test according to ISO 3826-1:2019, B.3 | N/A b | N/A b | Yes | Yes c | N/A b |
a Shall indicate which integral features are included. b Non-applicable. c Test for permanence of labelling need not include freezing at – 30 °C. d If a transparent over-package is used, all the information required under 8.3 should appear on the label of the plastics container. e Refer to ISO 3826-1:2019, 8.4 e) for applicability | ||||||
9.0 Anticoagulant and/or preservative solution
The quality of the anticoagulant and/or preservative solution, if any, shall satisfy the requirements of the national pharmacopoeia and national regulations.
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 and application of the edition of the normatively referenced standards as given in Table ZA.2 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 |
|---|---|---|
1. | 5.2.2, 5.2.3, 6, 7, 8, 9 | Requirement is partially covered by giving the state of the art of safe and effective performance and design requirements. Requirements outlined by the standard are considered state of the art. Normal conditions of use are determined by providing physical requirements (transparency, thermal stability, freezing, ionizing irradiation, water vapour transmission and resistance to leakage). Safety is covered with respect to physical requirements, chemical requirements and biological requirements. These requirements also address the manufacturing of the devices. The full assessment of risks is not addressed by the standard. |
3(d) | 8.2 (f), 8.2 (g), 8.2 (h) | Requirement is partially covered with respect to the control of the risk associated to the intended use and to the reasonably foreseeable misuse. Requirement is partially covered by designing labels including information for safety (single use instruction, instructions on deterioration, do not vent instruction). |
4(a) | 5.2.2, 5.2.3, 6, 7, 8, 9 | Requirement is partially covered with respect to the reduction of risks by giving the state of the art of safe design. Requirements outlined by the standard are considered state of the art. Safety is covered with respect to physical requirements, chemical requirements and biological requirements. These requirements also address the manufacturing of the devices. The full assessment of risks is not addressed by the standard. |
4(c) | 8.2(f), 8.2(g), 8.2(h) | Requirement is partially covered by designing labels including information for safety (single use instruction, instructions on deterioration, do not vent instruction). Requirements outlined by the standard are considered state of the art. The full assessment of risks is not addressed by the standard. |
6. | 5.2.2, 5.2.3, 6, 7, 8.3(d), 8.3(e), 8.4(d), 8.4(e), 9 | Requirements is partially covered by giving the state of the art of safe and effective performance and design requirements during the normal use throughout the lifetime of the device, and by providing instructions on the device lifetime. Normal conditions of use are determined by providing physical requirements (transparency, thermal stability, freezing, ionizing irradiation, water vapour transmission and resistance to leakage). Safety is covered with respect to physical requirements, chemical requirements and biological requirements. Manufacturer instructions on lifetime are provided by 8.3(d), 8.4(d) and 8.3(e), 8.4(e) requirements. The standard does not address the feedback from the market regarding the stresses that can occur during the normal conditions of use during the lifetime of the device. |
7. | 7, 8.3(d), 8.3(e), 8.4(d), 8.4(e), 8.4(f) | Requirements is partially covered with respect to packaging requirements (7) and labelling design providing information on expiry date, instructions on expiry after removal from over-package and storage conditions (8.3(d), 8.3(e), 8.4(d), 8.4(e), 8.4(f)). The standard does not address the transport. |
10.1(a) | 6.3, 6.4.1, 6.4.3, 9 | Requirement is covered by providing chemical and biological requirements for raw materials (6.3, 6.4.1, 6.4.3) and requirements for anticoagulant and/or preservative solutions (9). |
10.1(b) | 6.3.2, 6.4.1, 6.4.3 | Requirement is partially covered by providing chemical and biological requirements underlined by the standard. The standard does not address absorption, distribution, metabolism and excretion. |
10.1(d) | 6.1, 6.2.1, 6.2.2.2, 6.2.3, 6.2.4, 6.2.5, 6.2.6, 6.2.7, 6.2.8, 6.3, 6.4 |
|
10.1(f) | 6.1, 6.2.2.2, 6.2.5, 6.2.7 |
|
10.1(g) | 6.1, 6.2.3, 6.2.4, 8.5(g) |
|
10.1(h) | 5.2.2, 5.2.3, 6.1, 6.2, 6.3, 8.5(c), 8.5(d), 8.5(f), 8.5(g), 7, 9 |
|
10.2 | 6.2.1, 6.2.8, 6.3 6.4, 7, 9 | Requirement is partially covered with respect to conditions for manufacturing, particulate contamination, chemical and biological requirements, packaging requirements and requirements for anticoagulant and/or preservative solution. The standard does not address the persons involved in the transport, storage and use of the device. The standard does not address duration and frequency of exposure. |
10.4.1 | 6.2.2.2, 6.2.8, 6.3, 6.4.1, 6.4.3 | Requirement is partially covered by providing sterilization not affecting materials (6.2.2.2), particulate contamination minimization (6.2.8), chemical requirements (6.3) and biological requirements (6.4.1, 6.4.3). The standard does not address wear debris, processing residues and CMRs or endocrine-disruptors. |
10.5 | 6.2.1, 6.2.2.2, 6.2.5.2, 6.2.5.3, 6.2.7 | Requirement is partially covered by providing conditions of manufacture reducing the risk of contamination by foreign matter (6.2.1), sterilization not affecting joints and welds (6.2.2.2) and resistance to leakage (6.2.5.2, 6.2.5.3, 6.2.7). The standard does not address the nature of the environment in which the device is intended to be used. |
11.1 (c) | 6.2.5.2, 6.2.5.3, 6.2.7 | Requirement is partially covered by providing sterilization not affecting joints and welds (6.2.2.2) and resistance to leakage (6.2.5.2, 6.2.5.3, 6.2.7). The standard does not cover the reduction, as far as, possible, of any microbial leakage and/or exposure during use. |
11.1(d) | 6.2.1, 6.2.2, 6.2.5.2, 6.2.5.3, 6.2.7, 6.4.2 |
|
11.3 | 6.2.1, 6.4.2, 7 8.2(d), 8.4(f) | Requirement is partially covered with respect to conditions of manufacture (6.2.1), impermeability to micro-organisms (6.4.2), packaging (7), statement on sterility (8.2(d)) and storage conditions (8.4(f)). The standard does not address transport conditions. |
11.4 | 6.2.1, 6.2.2, 6.2.7, 6.4.2, 7, 8.2(d), 8.4(f) | Requirement is partially covered with respect to conditions of manufacture (6.2.1), sterilization (6.2.2), impermeability for micro-organisms (6.4.2), packaging (7) and statement on sterility and storage conditions on labels (8.2(d), 8.4(f)). The standard does not address the sterility of the product through transport until the point of use. The standard does not address the identification of the packaging which is intended to maintain the sterile condition. |
11.5 | 6.2.2.1 | Requirement is partially covered with respect to sterilization method validation. The standard does not address manufacturing and packaging methods’ validation. |
11.6 | 6.2.1 |
|
11.8 | 8.2(a), 8.2(b), 8.2(c), 8.2(e), 8.3(a), 8.3(b), 8.3(c) 8.4(a), 8.4(b), 8.4(c) | Requirement is covered for similar devices by giving manufacturer/supplier details, evidence of contents and use, anticoagulant/preservative formulation, which allow to distinguish between similar devices on the market. Requirements is covered for identical devices by also providing lot designation and expiry date, which allow to distinguish between identical devices. |
14.1 | 4, 6.2.2.2, 6.2.7 | Requirement is partially covered with respect to dimensions which allow safe connections (4), sterilization (6.2.2.2) and centrifugation (6.2.7). The standard does not address all possible combinations with other devices or equipment, nor the labelling requirements applying to such combinations. The standard does not address the design of connections by minimizing the risk of misconnections. |
23.1 (b) | 8.2, 8.3, 8.4 |
|
23.1 (h) | 8.1 | Requirements is partially covered with respect to the use of internationally recognised symbols, The standard does not address the documentation supplied with the device. |
23.2(a) | 8.2(b), 8.3(b), 8.4(b) | Requirement is covered by giving the description of the contents using the name or trade name of the device. |
23.2(b) | 8.2(b), 8.2(e), 8.3(b), 8.3(c), 8.4(b), 8.4(c) |
|
23.2(c) | 8.2(a), 8.3(a), 8.4(a) |
|
23.2(d) | 8.2 (a), 8.3(a), 8.4(a) |
|
23.2(e) | 8.2(c) | Requirements is partially covered by providing on the plastic container label the anticoagulant/preservative formulation, which may contain a medicinal substance. |
23.2(g) | 8.2(e), 8.3(c), 8.4(c) |
|
23.2(i) | 8.3(d), 8.3(e) 8.4(d), 8.4(e) | Requirement is partially covered with respect to providing an expiration date and the instructions on expiry after removal from over-package. The standard does not specify the format in terms of year and month. |
23.2(k) | 8.4 (f) | Requirement is partially covered by providing storage conditions information on the shipping box label. The standard does not address handling conditions. |
23.2(l) | 8.2 (d) |
|
23.2(m) | 8.2(f), 8.2(g), 8.2(h), 8.3(d), 8.3(e), 8.4(d), 8.4(e), 8.4(f) | Requirement is partially covered by providing warning or precautions on labels. The standard does not address the detail on the minimum information required and does not take into account the intended users. |
23.2(n) | 8.2(f) |
|
23.3(d) | 8.3(a) | Requirement is partially covered with respect to the name and address of the manufacturer on the over-package label. The standard does not address the packaging which maintains the sterile condition of a device. |
23.3(e) | 8.3(b) | Requirement is partially covered with respect to description of the content on the over-package label. The standard does not address the packaging which maintains the sterile condition of a device. |
23.3(i) | 8.3(d), 8.3(e) | Requirement is partially covered with respect to expiry date and instructions on expiry after removal from over-package, on the over-package label. The standard does not address the packaging which maintains the sterile condition of a device. |
Table ZA.2 — Normative references from clause 2 of this document and their corresponding European publications
Column 1 Reference in Clause 2 | Column 2 International Standard Edition | Column 3 Title | Column 4 Corresponding European Standard Edition |
|---|---|---|---|
ISO 3826-1:2019 | ISO 3826-1:2019 ISO 3826-1:2019/Amd 1:2023 | Plastics collapsible containers for human blood and blood components — Part 1: | EN ISO 3826-1:2019 EN ISO 3826-1:2019/A1:2023 |
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.
Impacted by ISO 3826-1:2019/Amd 1:2023. ↑
