oSIST prEN ISO 10555-5:2026

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

ISO 10555-5:2013 specifies requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use.

Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 5: Periphere Katheter mit innen liegender Kanüle (ISO/DIS 10555-5:2026)

Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 5: Cathéters intraveineux périphériques à aiguille interne (ISO/DIS 10555-5:2026)

L'ISO 10555-5:2013 spécifie les exigences générales relatives aux cathéters périphériques à aiguille interne, conçus pour accéder au système vasculaire périphérique, fournis dans des conditions stériles, non réutilisables.

Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 5. del: Periferni intravenski katetri z notranjo iglo (ISO/DIS 10555-5:2026)

General Information

• Status: Not Published
• Public Enquiry End Date: 29-Apr-2026
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 26-Feb-2026
• Due Date: 16-Jul-2026
• Ref Project: prEN ISO 10555-5 - Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral intravenous catheters (ISO/DIS 10555-5:2026)

Relations

• Revises: SIST EN ISO 10555-5:2013 - Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013)
• Effective Date: 15-Oct-2025

Overview

oSIST prEN ISO 10555-5:2026:2026 details the requirements for over-needle peripheral intravenous catheters. These sterile, single-use intravascular catheters are designed for accessing the peripheral venous system. Developed by CEN/ISO under technical committee ISO/TC 84, this standard supports consistency, quality, and safety in the manufacture and clinical use of intravenous catheters across healthcare settings.

Complying with oSIST prEN ISO 10555-5:2026 ensures catheters meet strict performance, identification, and safety criteria. The standard is particularly relevant for manufacturers, healthcare professionals, and regulatory authorities involved with peripheral venous access devices.

Key Topics

• Scope and Definitions

  • Applies exclusively to over-needle peripheral intravenous catheters.
  • Not intended for arterial catheter use.
  • Establishes clear definitions for key components, such as catheter, needle, hub, vent fitting, and flashback.

• Physical and Performance Requirements

  • Catheter Identification: Mandates a clear color-coding system for catheter size, enhancing clinical safety and efficiency.
  • Needle Construction: Requirements for material (referencing ISO 9626), sharpness, and integrity.
  • Needle Hub Union: Prescribes test methods to ensure secure connection, preventing detachment during use.
  • Vent Fitting: Specifies leakage testing procedures to ensure reliable performance and minimize risk of blood exposure.
  • Flashback Feature: Ensures visibility of blood return as verification of vein entry.

• Manufacturer Information

  • Requires comprehensive labeling, including product diameter and flowrate per lumen.
  • Provides warnings regarding safe use and re-insertion.

• Testing and Compliance

  • Outlines standard test methods for mechanical integrity, leakage, and identification.
  • Cites procedures for conditioning, testing atmospheric requirements, and performance thresholds.

Applications

oSIST prEN ISO 10555-5:2026:2026 is critical for:

• Medical Device Manufacturers

  • Provides a comprehensive framework for the design, production, and quality control of over-needle peripheral IV catheters.
  • Ensures global market access by aligning with international standards.

• Healthcare Providers

  • Assures clinicians of catheter reliability and safety, supporting effective peripheral venous access for infusion therapies and blood sampling.
  • Enhanced color-coded identification streamlines clinical workflows and minimizes errors.

• Regulatory Authorities

  • Used as a benchmark in medical device approval processes, supporting patient safety and regulatory compliance worldwide.

• Procurement and Hospital Administrators

  • Assists in evaluating and selecting compliant medical devices, ensuring supply chain quality and standardization.

Related Standards

The following standards are referenced within or closely related to oSIST prEN ISO 10555-5:2026:

• ISO 10555-1 - Intravascular catheters – General requirements: Fundamental requirements for all types of sterile single-use intravascular catheters.
• ISO 80369-7 - Small-bore connectors for liquids and gases in healthcare applications: Ensures safe connections for intravascular or hypodermic devices.
• ISO 9626 - Stainless steel needle tubing for the manufacture of medical devices: Material specifications for needle components.
• ISO 11070 - Sterile single-use intravascular introducers, dilators, and guidewires: Accessories for intravenous catheterization.
• ISO 14972 - Sterile obturators for single use with over-needle peripheral intravenous catheters.

Keywords: oSIST prEN ISO 10555-5:2026, over-needle peripheral intravenous catheters, sterile single-use catheters, intravascular access, color coding, catheter safety standard, ISO standards, medical device compliance

By implementing oSIST prEN ISO 10555-5:2026, organizations demonstrate commitment to high standards in the safety, identification, and functionality of over-needle peripheral intravenous catheters, thus supporting excellent patient care and regulatory compliance.

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2026
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 5. del: Periferni intravenski
katetri z notranjo iglo (ISO/DIS 10555-5:2026)
Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral
intravenous catheters (ISO/DIS 10555-5:2026)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 5: Periphere
Katheter mit innen liegender Kanüle (ISO/DIS 10555-5:2026)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 5: Cathéters
intraveineux périphériques à aiguille interne (ISO/DIS 10555-5:2026)
Ta slovenski standard je istoveten z: prEN ISO 10555-5
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 10555-5
ISO/TC 84
Intravascular catheters — Sterile
Secretariat: DS
and single-use catheters —
Voting begins on:
Part 5: 2026-02-17
Over-needle peripheral intravenous
Voting terminates on:
2026-05-12
catheters
ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 10555-5:2026(en)
DRAFT
ISO/DIS 10555-5:2026(en)
International
Standard
ISO/DIS 10555-5
ISO/TC 84
Intravascular catheters — Sterile
Secretariat: DS
and single-use catheters —
Voting begins on:
Part 5:
2026-02-17
Over-needle peripheral intravenous
Voting terminates on:
2026-05-12
catheters
ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 10555-5:2026(en)
ii
ISO/DIS 10555-5:2026(en)
Contents Page
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 .3
4.3 Physical requirements .3
4.3.1 Colour code .3
4.3.2 Catheter .3
4.3.3 Needle .3
4.3.4 Vent fitting .4
4.3.5 Flashback .4
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 . 9
Annex E (informative) Rationale for requirements . 14
Bibliography .15

iii
ISO/DIS 10555-5:2026(en)
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.

iv
DRAFT International Standard ISO/DIS 10555-5:2026(en)
Intravascular catheters — Sterile and single-use catheters —
Part 5:
Over-needle peripheral intravenous catheters
1 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 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 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)

ISO/DIS 10555-5:2026(en)
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)
l 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 Requirements
4.1 General
Unless otherwise specified in this document, over-needle peripheral intravenous catheters shall comply
with ISO 10555-1.
ISO/DIS 10555-5:2026(en)
4.2 Multilumen catheters
For multilumen catheters, identification of each lumen shall be apparent to the user.
4.3 Physical requirements
4.3.1 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
a,b c
Nominal outside diameter of Range of actual outside diam- Colour Gauge
catheter tube eter
mm mm
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
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