prEN ISO 10555-3
(Main)Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO/DIS 10555-3:2026)
General Information
- Abstract
ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.
- Status
- Not Published
- Publication Date
- 14-Sep-2027
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Current Stage
- 4060 - Closure of enquiry - Enquiry
- Start Date
- 12-May-2026
- Completion Date
- 12-May-2026
Overview
prEN ISO 10555-3:2026 defines the essential requirements for central venous catheters (CVCs) that are supplied sterile and intended for single use. This European and International Standard, developed by CEN and ISO/TC 84, ensures that CVCs meet stringent safety, performance, and quality criteria for medical devices that are critical for patient care. Central venous catheters are commonly used in clinical settings for the administration or withdrawal of fluids, medications, nutrients, and for monitoring central venous pressure. This standard does not cover peripherally inserted central catheters (see ISO 10555-7).
Key Topics
The standard focuses on several key aspects to promote patient safety and device reliability:
Sterility and Single-use Requirements
- Ensures CVCs are delivered in a sterile condition and are intended for one-time use to prevent infection and cross-contamination.
Distance Markings
- Requires clearly visible and accurate distance markings from the distal tip, typically no more than 5 cm between marks, to support precise catheter placement and monitoring.
Lumen Markings
- Stipulates that multilumen catheter designs must clearly identify each lumen, ensuring correct usage for varied clinical applications.
Peak Tensile Force
- Specifies minimum tensile force requirements for catheters, particularly at the tip when made of softer materials, to guarantee mechanical strength and reduce device failure risk.
Manufacturer Information
- Mandates comprehensive instructions and information from manufacturers, including:
- Flowrate for each lumen
- Maximum guidewire diameter
- Warnings about not withdrawing the catheter through the needle
- Recommended cleaning agents
- Specifics regarding power injectable catheters
- Mandates comprehensive instructions and information from manufacturers, including:
Applications
Central venous catheters covered by prEN ISO 10555-3:2026 are essential in various medical practices, including:
- Intensive Care Units (ICU)
- Used for the administration of medications, total parenteral nutrition, fluids, and blood sampling.
- Surgical Settings
- Permit intraoperative monitoring and fluid management.
- Chemotherapy and Long-term Therapies
- Enable repeated or continuous administration of chemotherapeutic agents or medications.
- Hemodynamic Monitoring
- Provide access for central venous pressure measurements necessary in critical care.
The standard’s emphasis on sterility and clear identification contributes to safer clinical outcomes, reduced risk of catheter-related infections, and improved overall patient care.
Related Standards
For comprehensive conformance and to support various clinical scenarios, the following related standards should be referenced in conjunction with prEN ISO 10555-3:
- ISO 10555-1: Intravascular catheters - Part 1: General requirements - Base standard for all types of sterile, single-use intravascular catheters.
- ISO 10555-7: Intravascular catheters - Sterile and single-use catheters - Part 7: Peripherally inserted central catheters (PICC) - Specifies requirements for PICCs, which are not covered in Part 3.
- ISO 11070: Sterile single-use intravascular introducers, dilators, and guidewires - Pertains to accessory devices commonly used with CVCs.
Manufacturers, clinical practitioners, and healthcare facilities should ensure that central venous catheters comply with prEN ISO 10555-3:2026 to meet regulatory requirements and uphold patient safety across healthcare environments.
Relations
- Effective Date
- 15-Oct-2025
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Frequently Asked Questions
prEN ISO 10555-3 is a draft published by the European Committee for Standardization (CEN). Its full title is "Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO/DIS 10555-3:2026)". This standard covers: ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.
ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.
prEN ISO 10555-3 is classified under the following ICS (International Classification for Standards) categories: 11.040.25 - Syringes, needles an catheters. The ICS classification helps identify the subject area and facilitates finding related standards.
prEN ISO 10555-3 has the following relationships with other standards: It is inter standard links to EN ISO 10555-3:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
prEN ISO 10555-3 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2026
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 3. del: Osrednji venski
katetri (ISO/DIS 10555-3:2026)
Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous
catheters (ISO/DIS 10555-3:2026)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 3: Zentrale
venöse Katheter (ISO/DIS 10555-3:2026)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 3: Cathéters
centraux veineux (ISO/DIS 10555-3:2026)
Ta slovenski standard je istoveten z: prEN ISO 10555-3
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 10555-3
ISO/TC 84
Intravascular catheters — Sterile
Secretariat: DS
and single-use catheters —
Voting begins on:
Part 3: 2026-02-17
Central venous catheters
Voting terminates on:
2026-05-12
Cathéters intravasculaires — Cathéters stériles et non
réutilisables —
Partie 3: Cathéters centraux veineux
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 10555-3:2026(en)
DRAFT
ISO/DIS 10555-3:2026(en)
International
Standard
ISO/DIS 10555-3
ISO/TC 84
Intravascular catheters — Sterile
Secretariat: DS
and single-use catheters —
Voting begins on:
Part 3:
2026-02-17
Central venous catheters
Voting terminates on:
2026-05-12
Cathéters intravasculaires — Cathéters stériles et non
réutilisables —
Partie 3: Cathéters centraux veineux
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: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 10555-3:2026(en)
ii
ISO/DIS 10555-3:2026(en)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 1
4.1 General .1
4.2 Distance markings .1
4.3 Lumen markings .2
4.4 Peak tensile force .2
4.5 Information to be supplied by the manufacturer .2
Bibliography . 3
iii
ISO/DIS 10555-3:2026(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of nat
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