prEN ISO 10555-5

prEN ISO 10555-5: Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral intravenous catheters (ISO/DIS 10555-5:2026)

ISO/DIS 10555-5:2026(en)

ISO/TC 84

Secretariat: DS

Date: 2025-12-23

Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral intravenous catheters

Cathéters intravasculaires — Cathéters stériles et non réutilisables — Partie 5: Cathéters périphériques à aiguille interne

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Contents

Foreword iv

1 Scope 1

2 Normative references 1

3 Terms and definitions 1

4 Requirements 2

4.1 General 2

4.2 Multilumen catheters 2

4.3 Physical requirements 3

4.4 Information to be supplied by the manufacturer 4

Annex A (normative) Determination of strength of union of needle hub and needle tube 5

Annex B (informative) Colours for opaque catheter hubs 6

Annex C (informative) Needle point geometries 7

Annex D (normative) Determination of liquid leakage from vent fitting 8

D.1 Principle for Test A 8

D.2 Test fluid for Test A 8

D.3 Apparatus for Test A 8

D.4 Procedure for Test A 8

D.5 Test report for Test A 8

D.6 Principle for Test B 10

D.7 Test fluid for Test B 10

D.8 Apparatus for Test B 10

D.9 Procedure for Test B 10

D.10 Test report for Test B 10

Annex E (informative) Rationale for requirements 12

Bibliography 13

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).

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.

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 84, Devices for administration of medicinal products and intravascular catheters.

This third edition cancels and replaces the second edition (ISO 10555-5:2013), which has been technically revised.

The main changes are as follows:

— xxx xxxxxxx xxx xxxx:

Drafting note: list will be inserted after DIS stage.

A list of all parts in the ISO 10555-series can be found on the ISO website.

Attention is drawn to ISO 11070, which specifies requirements for accessory devices for use with intravenous catheters, and to ISO 14972, which specifies requirements for sterile obturators for use with over-needle peripheral intravenous catheters.

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.

Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral intravenous catheters

1.0 Scope

This document specifies requirements for over-needle peripheral intravenous catheters, intended for accessing the peripheral venous system, supplied in the sterile condition and intended for single 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 80369‑7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications

ISO 9626, Stainless steel needle tubing for the manufacture of medical devices

ISO 10555‑1, Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements

3.0 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 10555-1 and the following apply.

NOTE See Figure 1 for visual representation of definitions with exception of 3.7.

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

over-needle peripheral intravenous catheter

catheter designed for the introduction or withdrawal of liquids or devices into or from the peripheral venous system

3.2

needle

assembly comprising at least a needle tube (3.3) attached to, and communicating with, a needle hub (3.4)

3.3

needle tube

rigid tube with one end sharpened with a bevel to facilitate entry into body tissue

3.4

needle hub

fitting attached to the needle tube (3.3)

3.5

vent fitting

fixed or removable fitting permitting venting of air while restricting or preferably preventing the escape of blood

3.6

catheter

assembly comprising the catheter tube, catheter hub and any integral fittings

3.7

flashback

blood flow into the needle (3.2) or catheter tube

Note 1 to entry: Rationale for removing hub and adding catheter tube.

3.8

needle point

entire sharpened section of the distal end of the needle tube (3.3)

Key

a 0 < a < 1 mm (see 4.3.2)

l₁ effective length

1 catheter tube

2 catheter hub

3 needle tube (3.3)

4 needle hub (3.4)

5 vent fitting (3.5)

6 heel of needle point

7 catheter (3.6)

8 needle point (3.8)

NOTE Other design features can include wings, injection ports integral with the catheter hub, other means of connecting to the fluid path, protection against accidental needle stick injury, etc. The catheter tube can have a single lumen or multiple lumens.

Figure 1 — Typical over-needle peripheral intravenous catheter

4.0 Requirements

4.1 General

Unless otherwise specified in this document, over-needle peripheral intravenous catheters shall comply with ISO 10555‑1.

4.1.1 Multilumen catheters

For multilumen catheters, identification of each lumen shall be apparent to the user.

4.1.2 Physical requirements

4.1.3 Colour code

The catheter shall be colour coded in accordance with Table 1 to indicate the nominal outside diameter of the catheter tube.

Table 1 — Colour coding and corresponding sizes of catheter

Nominal outside diameter of catheter tube mm	Range of actual outside diameter mm	Colour^a,b	Gauge^c
0,6	0,550 to 0,649	Violet	26
0,7	0,650 to 0,749	Yellow	24
0,8; 0,9	0,750 to 0,949	Deep blue	22
1,0; 1,1	0,950 to 1,149	Pink	20
1,2; 1,3	1,150 to 1,349	Deep green	18
1,4; 1,5	1,350 to 1,549	White	17
1,6; 1,7; 1,8	1,550 to 1,849	Medium grey	16
1,9; 2,0; 2,1; 2,2	1,850 to 2,249	Orange	14
2,3; 2,4; 2,5	2,250 to 2,549	Red	13
2,6; 2,7; 2,8	2,550 to 2,849	Pale blue	12
3,3; 3,4	3,250 to 3,549	Light brown	10
^a The colour may be opaque or translucent. Suggested colour references for opaque materials are given in Annex B. ^b The colour coding is usually applied to the catheter hub or to an integral fitting. ^c The use of gauge number is optional.

4.1.4 Catheter

The distal end shall be tapered for ease of insertion and shall fit closely to the needle. When the needle is fully inserted into the catheter, the catheter tube shall neither extend beyond the heel of the needle point nor be more than 1 mm from it (see dimension a in Figure 1).

4.1.5 Needle

Needle tube material

If a steel tube is used, it shall comply with ISO 9626, except for the roundness requirement in areas where roundness is intentionally modified (e.g. crimp, notch, groove, etc.).

Needle point

When examined by normal or corrected-to-normal vision with × 2,5 magnification, the needle point shall appear sharp and free from feather edges, burrs and hooks.

NOTE Annex C shows examples of typical needle point geometries.

Needle hub

If the needle is provided with a removable vent fitting, the needle hub shall terminate in a female fitting complying with ISO 80369-7.

Strength of union between needle hub and needle tube

When tested in accordance with Annex A, the needle tube shall not be loosened in the needle hub.

4.1.6 Vent fitting

A vent fitting shall be provided. When tested in accordance with Annex D, fluid shall not leak out of the vent fitting within 15 s. In Annex D, either test A or B shall be used.

4.1.7 Flashback

The needle hub and/or another feature shall facilitate detection of flashback.

4.2 Information to be supplied by the manufacturer

Information supplied by the manufacturer shall comply with ISO 10555‑1 and shall also include the following:

a) the flowrate for each lumen;

b) a warning against attempting to re-insert a partially or completely withdrawn needle;

c) on each primary packaging, the corresponding product colour (see Table 1), unless the colour on the product is visible through the primary packaging, and the outside diameter, as defined in Table 1.

Units of measurement systems other than those specified may additionally be given.

(normative)

Determination of strength of union of needle hub and needle tube
1. Principle

A force is applied (successively tensile and compressive) to the needle tube and needle hub and the tube-hub union is then examined for loosening.

1. Apparatus

Tensile testing apparatus, capable of exerting forces of up to 20 N with an accuracy of ±1 % or better.

1. Test procedure

A.3.1 Condition the needle in an atmosphere of 40 % to 60 % relative humidity and a temperature of (22 ± 5) °C for a minimum of 2 h immediately before the test.

A.3.2 Clamp the needle tube and the needle hub in the jaws of the tensile testing apparatus and apply successively, once each, at a maximum rate of 100 mm/min, a tensile and a compressive force of:

— 10 N when testing needles of nominal outside diameter less than 0,6 mm;

— 20 N when testing needles of nominal outside diameter 0,6 mm or greater.

A.3.3 Examine the union of needle tube and needle hub and record whether the needle tube has been loosened.

1. Test report

The test report shall include the following information:

a) identity of the test samples;

b) outside diameter of the needle, expressed in millimetres;

c) load applied (i.e. 10 N or 20 N);

d) a reference to this document (including its year of publication) and annex;

e) statement as to whether or not the needle tube was loosened in the hub;

f) any deviations from the procedure;

g) the date of the test.

(informative)

Colours for opaque catheter hubs

Suggested colour references are given for information in Table B.1.

Table B.1 — Suggested colour references for opaque catheter hubs

Nominal outside diameter of catheter tube mm	Colour code	Munsell Atlas^[5]	US Federal Standard 595a^[6]	DIN 6164‑1^[3]	NF X 08‑002^[4]
0,6	Violet	5 P 6.5/6	—	—	A 2790
0,7	Yellow	3.75 Y 8/14	23 655	1.9; 6.8; 0.7	A 330
0,8; 0,9	Deep blue	2.5 PB 3/8	15 090	16.6; 6.5; 4.2	A 540
1,0; 1,1	Pink	2.5 R 7/6	11 630	8.5; 1.4; 1.5	A 870
1,2; 1,3	Deep green	2.5 G 4/8	14 090	22.6; 6.9; 5.0	A 455
1,4; 1,5	White	N 9.5	27 875	1.0; 0.4; 0.3	A 665
1,6; 1,7; 1,8	Medium grey	N 7	26 231	24.4; 0.2; 3.9	A 630
1,9; 2,0; 2,1; 2,2	Orange	3.75 YT 6/12	12 473	4.5; 6.6; 1.7	A 130
2,3; 2,4; 2,5	Red	7.5 R 4/14	—	7.4; 7.9; 2.7	A 801
2,6; 2,7; 2,8	Pale blue	2.5 PB 7/8	35 190	17.5; 4.4; 2.0	A 590
3,3; 3,4	Light brown	7.5 YR 4.5/6	—	—	A 2030

(informative)

Needle point geometries

Typical needle point geometries are shown for information in Figure C.1.

Key

d₀ outside diameter of the needle tube

d₁ inside diameter of the needle tube

l needle point length

l₁ primary bevel nominal length

l₂ secondary bevel nominal length

α primary bevel angle

β tip angle

θ₂ secondary bevel rotation angle

γ combined secondary bevel angle

Figure C.1 — Examples of typical needle point geometries

(normative)

Determination of liquid leakage from vent fitting
1. Principle for Test A

The needle is connected to a source of simulated blood under hydrostatic pressure. The fluid is allowed to flow into the needle for 15 s and whether or not leakage occurred is recorded.

1. Test fluid for Test A

D.2.1 Prepare a solution of 0,9 % sodium chloride by dissolving reagent grade sodium chloride in distilled or deionized water in a 9 g sodium chloride / 1 l water m/V ratio.

D.2.2 Prepare the test fluid by mixing sodium chloride solution (D.2.1) and glycerol of 99 % purity or higher in a 55 % sodium chloride / 45 % glycerol V/V ratio.

NOTE See Annex E for additional information.

1. Apparatus for Test A

D.3.1 Constant-level tank, to provide a hydrostatic head of (400 ± 20) mm (to produce a pressure of 3 923 ± 196 Pa), fitted with a delivery tube of inside diameter not less than 3 mm having a clamp or valve and at its end a puncturable membrane (e.g. a latex cap). See Figure D.1 for an example of such apparatus.

The pressure experienced during clinical use can be greater than the values listed above. If the pressure experienced during clinical use is determined by the manufacturer to be greater than the values listed above, a clinically relevant hydrostatic head may be used.

D.3.2 Stopwatch, or similar device.

1. Procedure for Test A

D.4.1 Supply the constant-level tank (D.3.1) with test fluid (D.2) at (23 ± 2) °C and perform the test at room temperature of (23 ± 2) °C.

D.4.2 Remove all air from the delivery tube and close the clamp or valve.

D.4.3 Insert the tip of the needle tube through the membrane, ensuring that the needle tube is kept horizontal at ±5°.

D.4.4 Open the clamp or valve so as to allow fluid to enter the needle tube. Maintain the hydrostatic head for a minimum of 15 s while examining the vent fitting for liquid leakage, i.e. the formation of one or more falling drops of test fluid, and record whether or not leakage occurs.

1. Test report for Test A

The test report shall contain at least the following information:

a) the identity of the test samples being tested;

b) a reference to this document (including its year of publication) and annex;

c) statement as to whether or not leakage occurred within 15 s;

d) If variable data method is used for data analysis, report the time, in s, for the first drop of test fluid to fall

e) any deviations from the procedure;

f) the date of the test.

Dimensions in millimetres

Key

1 constant-level tank

2 overflow

3 inlet

4 test fluid

5 clamp or valve

6 needle tube

7 membrane

8 vent fitting

9 delivery tube

^a Internal diameter.

Figure D.1 — Example of apparatus for determination of liquid leakage from vent fitting by Test A

1. Principle for Test B

The needle is connected to a pressure generating source. The pressure generating device shall apply fluid into the needle for 15 s and whether or not leakage occurred is recorded.

1. Test fluid for Test B

D.7.1 Prepare a solution of 0,9 % sodium chloride by dissolving reagent grade sodium chloride in distilled or deionized water in a 9 g sodium chloride / 1 l water m/V ratio.

D.7.2 Prepare the test fluid by mixing sodium chloride solution (D.7.1) and glycerol of 99 % purity or higher in a 55 % sodium chloride / 45 % glycerol V/V ratio.

NOTE See Annex E for additional information.

1. Apparatus for Test B

D.8.1 Pressure generating device, which supplies the test fluid, fitted with a pressure gauge and capable of at least 3 923 ± 196 Pa.

D.8.2 Connector, to make a leak proof connection between the pressure generating device and puncturable membrane.

D.8.3 Puncturable membrane, e.g. a latex cap or hemostasis valve, inside diameter not less than 3 mm, to make a leak proof connection between the connector and needle tube. See Figure D.2 for an example of such apparatus.

D.8.4 Stopwatch, or similar device.

1. Procedure for Test B

D.9.1 Connect the puncturable membrane to the pressure generating device by means of a connector.

D.9.2 Purge the pressure generating device (D.8.1) with test fluid (D.7) at (23 ± 2) °C and expel the air. Perform the test at room temperature of (23 ± 2) °C.

D.9.3 Insert the tip of the needle tube through the membrane, ensuring that the needle tube is kept horizontal at ±5°.

D.9.4 Apply a pressure of 3 923 ± 196 Pa. Maintain the pressure for a minimum of 15 s while examining the vent fitting for liquid leakage, i.e. the formation of one or more falling drops of test fluid, and record whether or not leakage occurs.

1. Test report for Test B

The test report shall contain at least the following information:

a) the identity of the test samples being tested;

b) a reference to this document (including its year of publication) and annex;

c) minimum and maximum pressure achieved, Pa;

d) statement as to whether or not leakage occurred;

e) if variable data method is used for data analysis, report the time, in s, for the first drop of test fluid to fall;

f) any deviations from the procedure;

g) the date of the test.

Key

1 pressure generating device

2 valve for initiating and terminating flow

3 pressure transducer

4 membrane

5 needle tube

6 vent fitting

Figure D.2 — Example of apparatus for determination of liquid leakage from vent fitting by Test B

(informative)

Rationale for requirements

Table E.1 — Rationale for requirements

No	Clause/subclause, figure, table	Rationale
1	1 Scope	The original scope of this document covers over the needle catheters inserted into peripheral arterial and venous systems. Over the needle catheters used for peripheral venous system are compliant to this standard. However, over the needle peripheral arterial catheters are largely not compliant to some requirements in the standard such as 4.3.1 Colour code. Some of the requirements such as 4.3.4 Vent fitting is not adequate for arterial catheters. Therefore, the scope of the standard is modified to be only applicable to over the needle peripheral intravenous catheters. Future inclusion of arterial catheters can be considered if market needs arise.
2	3.1 over-needle peripheral intravenous catheter	The change in the definition is made to be in line with the scope change.
3	3.8 Needle point	This definition is added because requirement 4.3.3.2 is about Needle point which was not defined in the 2^nd edition of the standard.
4	4.3.3.2 Needle point NOTE	The needle point geometry examples in Annex C are actually coring needle tip though not significant. The first part of the note was removed to reflect this fact.
5	4.3.3.3 Needle Hub	4.3.3.3 Needle hub clause is confusing since it listed two separate requirements: flashback for the catheter and female fitting in the needle hub if provided with a removable vent fitting. Changes are made to have two separate requirements to minimize confusion.
6	4.3.5 Flashback	4.3.5 Flashback is separated out of the original 4.3.3.3 to be a standalone requirement to minimize confusion. In addition, there are devices where flashback is not provided by needle hub. Therefore, this requirement should not be under 4.3.3 Needle.
7	D.2.1	The original wording appears to ask the operator to make only 1 l of sodium chloride solution. The change reflects the intent of the statement which is to make 0,9 % sodium chloride solution of any volume as needed.
8	D.2.2	Two changes are made. The purity of glycerol was specified as 9 9 % which was equivalent to USP grade or better. This eliminates the potential inconsistency in interpreting the definition of USP grade. The second change is to replace the specific volume sizes in mixing the test fluid with ratio of sodium chloride solution and glycerol to allow the freedom of making any size of test fluid.
9	D.6 – D.10	A second test method is added to Annex D to allow the use of constant pressure source.
10	D.6.5 c) and d) D.10 d) and e)	The changes are made to allow both attribute and variable based test analysis methods

Bibliography

[1] ISO 11070, Sterile single-use intravascular introducers, dilators and guidewires

[2] ISO 14972, Sterile obturators for single use with over-needle peripheral intravascular catheters

[3] DIN 6164‑1, DIN Farbenkarte; System der DIN Farbenkarte für den 2°-Normalbeobachter. Available from Beuth Verlag GmbH, Burggrafenstrasse 6, D-10787 Berlin, Germany

[4] NF X 08 002, Collection réduite des couleurs — Désignation et catalogue des couleurs CCR — Étalons secondaires. (Limited collection of colours. Designation and catalogue of CCR colours. Secondary standards.) Available from AFNOR, Tour Europe, Cedex 7, F-92080 Paris La Défense, France

[5] Munsell Book of Color. Available from Munsell Color, 2441 N. Calvert Street, Baltimore, MD 21218 USA

[6] US Federal Standard 595a: Colors, Volume 1. Available from Superintendent of Documents, US Government Printing Office, Washington DC, 20402 USA

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