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CEN

EN ISO 10555-1:2023

(Main)

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

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 ist nicht anwendbar 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)

Ta dokument določa splošne zahteve za žilne katetre, dobavljene v sterilnem stanju in namenjene za enkratno uporabo, za katero koli vrsto uporabe.
Ta dokument se ne uporablja za dodatke žilnih katetrov, npr. tiste iz standarda ISO 11070.

General Information

Status
Published
Publication Date
28-Nov-2023
ICS
11.040.25 - Syringes, needles an catheters
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205 - Non-active medical devices
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
29-Nov-2023
Completion Date
29-Nov-2023
Ref Project
SIST EN ISO 10555-1:2024 - Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023)

Relations

Replaces
EN ISO 10555-1:2013/A1:2017 - Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements - Amendment 1 (ISO 10555-1:2013/Amd 1:2017)
Effective Date
18-Jan-2023
Replaces
EN ISO 10555-1:2013 - Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, Corrected version 2014-01-15)
Effective Date
18-Jan-2023

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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
...

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