Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements - Amendment 1 (ISO 10555-1:2013/Amd 1:2017)

DOW = DAV + 36 months

Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1: Allgemeine Anforderungen - Änderung 1 (ISO 10555-1:2013/DAmd 1:2016)

Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences générales - Amendement 1 (ISO 10555-1:2013/DAmd 1:2016)

Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve - Dopolnilo A1 (ISO 10555-1:2013/Amd 1:2017)

General Information

Status
Published
Public Enquiry End Date
09-May-2016
Publication Date
21-Jan-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
05-Jan-2018
Due Date
12-Mar-2018
Completion Date
22-Jan-2018

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SLOVENSKI STANDARD
SIST EN ISO 10555-1:2013/A1:2018
01-februar-2018

Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve -

Dopolnilo A1 (ISO 10555-1:2013/Amd 1:2017)

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements -

Amendment 1 (ISO 10555-1:2013/Amd 1:2017)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1:
Allgemeine Anforderungen - Änderung 1 (ISO 10555-1:2013/DAmd 1:2016)

Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences

générales - Amendement 1 (ISO 10555-1:2013/DAmd 1:2016)
Ta slovenski standard je istoveten z: EN ISO 10555-1:2013/A1:2017
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-1:2013/A1:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10555-1:2013/A1:2018
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SIST EN ISO 10555-1:2013/A1:2018
EN ISO 10555-1:2013/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2017
EUROPÄISCHE NORM
ICS 11.040.25
English Version
Intravascular catheters - Sterile and single-use catheters -
Part 1: General requirements - Amendment 1 (ISO 10555-
1:2013/Amd 1:2017)

Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur

réutilisables - Partie 1: Exigences générales - einmaligen Verwendung - Teil 1: Allgemeine

Amendement 1 (ISO 10555-1:2013/Amd 1:2017) Anforderungen - Änderung 1 (ISO 10555-1:2013/Amd

1:2017)

This amendment A1 modifies the European Standard EN ISO 10555-1:2013; it was approved by CEN on 15 December 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of

this amendment into the relevant 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 amendment 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey 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

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-1:2013/A1:2017 E

worldwide for CEN national Members.
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SIST EN ISO 10555-1:2013/A1:2018
EN ISO 10555-1:2013/A1:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 10555-1:2013/A1:2018
EN ISO 10555-1:2013/A1:2017 (E)
European foreword

This document (EN ISO 10555-1:2013/A1:2017) 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 Amendment to the European Standard EN ISO 10555-1:2013 shall be given the status of a national

standard, either by publication of an identical text or by endorsement, at the latest by June 2018, and

conflicting national standards shall be withdrawn at the latest by December 2021.

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 has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, included in EN ISO 10555-1:2013.

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, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

...

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