ISO/DIS 10555-3:2026(en)

ISO/TC 84

Secretariat: DS

Date: 2025-12-23

Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters

Cathéters intravasculaires — Cathéters stériles et non réutilisables — Partie 3: Cathéters centraux veineux

© ISO 2026

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.

ISO copyright office

CP 401 • Ch. de Blandonnet 8

CH-1214 Vernier, Geneva

Phone: +41 22 749 01 11

Email: copyright@iso.org

Website: www.iso.org

Published in Switzerland

Contents

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 1

4.4 Peak tensile force 2

4.5 Information to be supplied by the manufacturer 2

Bibliography 3

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 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 catheters.

This third edition cancels and replaces the second edition (ISO 10555‑3:2013), 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 intravascular 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 3: Central venous catheters

This document specifies requirements for central venous catheters supplied in the sterile condition and intended for single use.

Peripherally Inserted Central Catheters (PICC) are not part of this document, (see ISO 10555-7).

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 10555‑1:2023, Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements

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

central venous catheter

intravascular catheter, single- or multilumen, designed for introduction into, or withdrawal of liquids from, the central venous system and/or for pressure or other measurements

Note 1 to entry: The catheter can have a fixation system which is part of the device.

Catheters shall comply with ISO 10555‑1, except for the peak tensile force (see ISO 10555‑1:2023, 4.9), for which the requirements of 4.4 of this document shall apply.

If the catheter is provided with distance markings, the marking system shall indicate distance from the distal end. From the first mark, the distance between marks shall not exceed 5 cm.

It is recommended that the distance marks be 1 cm apart on that portion of the catheter likely to be of importance to the user in positioning the catheter and monitoring catheter migration.

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

For catheters having a tip of softer material or of different construction to the shaft and not exceeding 20 mm in length, the minimum peak tensile force of the tip shall be as given in Table 1 when tested in accordance with the method given in ISO 10555‑1:2023, Annex B.

For distal tips of less than 3 mm length, the peak tensile force requirement shall be as given in ISO 10555-1.

The minimum peak tensile force of all other parts of such catheters shall comply with ISO 10555‑1:2023, 4.9.

Table 1 — Minimum peak tensile force of soft tips of length not exceeding 20 mm

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

a) flowrate for each lumen;

b) maximum guidewire diameter, where applicable;

c) if applicable, a warning against attempting to withdraw the catheter back through the needle;

d) at least one recommended cleaning agent for site maintenance;

e) for each lumen of a power injectable catheter, an indication of whether the lumen is compatible with power injection.

NOTE Units of measurement other than those specified in this document can additionally be used.

Bibliography

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

[2] ISO 10555‑7, Intravascular catheters — Sterile and single-use catheters — Part 7: Peripherally inserted central catheters