ISO 10555-7:2023

Intravascular catheters — Sterile and single-use catheters — Part 7: Peripherally inserted central catheters

This document specifies general requirements and test method for peripherally inserted central catheters (PICC), supplied in the sterile condition and intended for single use, for any application. It is not applicable to intravascular catheter accessories, e.g. those covered by ISO 11070.

Cathéters intravasculaires — Cathéters stériles et non réutilisables — Partie 7: Cathéters centraux à insertion périphérique

Le présent document spécifie les exigences générales et la méthode d’essai relatives aux cathéters centraux à insertion périphérique (peripherally inserted central catheters, PICC), fournis stériles et non réutilisables, destinés à toute application. Il n’est pas applicable aux accessoires de cathéters intravasculaires, par exemple ceux couverts par l’ISO 11070.

General Information

• Status: Published
• Publication Date: 17-Dec-2023
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: ISO/TC 84 - Devices for administration of medicinal products and catheters
• Drafting Committee: ISO/TC 84/WG 9 - Catheters
• Current Stage: 6060 - International Standard published
• Start Date: 18-Dec-2023
• Due Date: 19-Aug-2025
• Completion Date: 18-Dec-2023

Standards Content (Sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 10555-7
ISO/TC 84
Intravascular catheters — Sterile and
Secretariat: DS
single-use catheters —
Voting begins on:
2023-09-26
Part 7:
Voting terminates on:
Peripherally inserted central
2023-11-21
catheters
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 7: Cathéters centraux à insertion périphérique
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 10555-7:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 1 ----------------------
ISO/FDIS 10555-7:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 10555-7
ISO/TC 84
Intravascular catheters — Sterile and
Secretariat: DS
single-use catheters —
Voting begins on:
Part 7:
Voting terminates on:
Peripherally inserted central
catheters
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 7: Cathéters centraux à insertion périphérique
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 10555-7:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 2 ----------------------
ISO/FDIS 10555-7:2023(E)
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 Distance markings . 2
4.3 Lumen markings . 2
4.4 Peak tensile force . 2
4.4.1 General . 2
4.4.2 Catheters excluding the tip . 2
4.
...

ISO /DIS/FDIS 10555-7:2022(E)
Date: 2023-06-28
ISO/TC 84/WG 9 N 897
Replaces N 896
Secretariat: DS
Date: 2023-09-12
Intravascular catheters — Sterile and single-use catheters — —
Part 7:
Peripherally inserted central catheters



DIS stage

This document contains the result of the discussions of the comments received on ISO/DIS 10555-7.

The comments with WG observations is circulated as document N 895 and a track changes version of
this draft is circulated as document N 896.

Project leader: Alex Kraemer (US)

Next step: After final WG 9 check for obvious editorial errors (to be reported to DS before 1 August
2023) this draft will be sent to ISO/CS for initiation of the FDIS procedure.

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© ISO 2022
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 7: Cathéters centraux à insertion périphérique
FDIS stage

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ISO/DISFDIS 10555-7:20222023(E) (N897)
© ISO 2023
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
Fax: [phone]
EmailE-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
© ISO 2023 – All rights reserved iii
© ISO 2022 – All rights reserved iii

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ISO/DISFDIS 10555-7:20222023(E) (N897)
Contents
Foreword . v
Part 7: Peripherally inserted central catheters . 1
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Distance markings . 2
4.3 Lumen markings . 2
4.4 Peak tensile force . 2
4.4.1 General . 2
4.4.2 Catheters excluding the tip . 2
4.4.3 Tip tensile force . 2
4.5 Information to be supplied by the manufacturer . 3
Annex A (informative) Rationale and guidance . 4
A.1 General . 4
A.2 Background . 4
A.3 Method .
...