Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023)

This document specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application.
This document does not apply to intravascular catheter accessories, e.g. those covered by ISO 11070.

Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1: Allgemeine Anforderungen (ISO 10555-1:2023)

Dieses Dokument legt allgemeine Anforderungen an intravaskuläre Katheter jedes Verwendungszwecks fest, die steril geliefert werden und zur einmaligen Verwendung bestimmt sind.
Dieses Dokument gilt nicht für Zubehörteile zu intravaskulären Kathetern, z. B. die in ISO 11070 behandelt werden.

Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences générales (ISO 10555-1:2023)

Le présent document spécifie les exigences générales relatives aux cathéters intravasculaires fournis stériles et non réutilisables, destinés à toute application.
Le présent document ne s’applique pas aux accessoires de cathéters intravasculaires, qui sont couverts par l’ISO 11070.

Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve (ISO 10555-1:2023)

General Information

Status
Published
Public Enquiry End Date
30-Jan-2023
Publication Date
08-Feb-2024
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
24-Jan-2024
Due Date
30-Mar-2024
Completion Date
09-Feb-2024

Relations

Buy Standard

Standard
EN ISO 10555-1:2024
English language
52 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day
Draft
prEN ISO 10555-1:2023
English language
48 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10555-1:2024
01-marec-2024
Nadomešča:
SIST EN ISO 10555-1:2013
SIST EN ISO 10555-1:2013/A1:2018
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve
(ISO 10555-1:2023)
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
(ISO 10555-1:2023)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1:
Allgemeine Anforderungen (ISO 10555-1:2023)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences
générales (ISO 10555-1:2023)
Ta slovenski standard je istoveten z: EN ISO 10555-1:2023
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-1:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 10555-1:2024

---------------------- Page: 2 ----------------------
SIST EN ISO 10555-1:2024


EN ISO 10555-1
EUROPEAN STANDARD

NORME EUROPÉENNE

November 2023
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 10555-1:2013
English Version

Intravascular catheters - Sterile and single-use catheters -
Part 1: General requirements (ISO 10555-1:2023)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur
réutilisables - Partie 1: Exigences générales (ISO einmaligen Verwendung - Teil 1: Allgemeine
10555-1:2023) Anforderungen (ISO 10555-1:2023)
This European Standard was approved by CEN on 24 November 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-1:2023 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 10555-1:2024
EN ISO 10555-1:2023 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 10555-1:2024
EN ISO 10555-1:2023 (E)
European foreword
This document (EN ISO 10555-1:2023) has been prepared by Technical Committee ISO/TC 84 "Devices
for administration of medicinal products and catheters" in collaboration with Technical Committee
CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2024, and conflicting national standards shall be
withdrawn at the latest by May 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10555-1:2013.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10555-1:2023
...

SLOVENSKI STANDARD
oSIST prEN ISO 10555-1:2023
01-januar-2023
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve
(ISO/DIS 10555-1:2022)
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
(ISO/DIS 10555-1:2022)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1:
Allgemeine Anforderungen (ISO/DIS 10555-1:2022)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences
générales (ISO/DIS 10555-1:2022)
Ta slovenski standard je istoveten z: prEN ISO 10555-1
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 10555-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 10555-1:2023

---------------------- Page: 2 ----------------------
oSIST prEN ISO 10555-1:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10555-1
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2022-11-22 2023-02-14
Intravascular catheters — Sterile and single-use
catheters —
Part 1:
General requirements
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 1: Exigences générales
ICS: 11.040.25
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10555-1:2022(E)
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. © ISO 2022

---------------------- Page: 3 ----------------------
oSIST prEN ISO 10555-1:2023
ISO/DIS 10555-1:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10555-1
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:

Intravascular catheters — Sterile and single-use
catheters —
Part 1:
General requirements
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 1: Exigences générales
ICS: 11.040.25
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 10555-1:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

---------------------- Page: 4 ----------------------
oSIST prEN ISO 10555-1:2023
ISO/DIS 10555-1:2022(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references .
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.