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SIST EN ISO 10555-1:2013/A1:2018

(Amendment)

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

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
Withdrawn
Public Enquiry End Date
09-May-2016
Publication Date
21-Jan-2018
Withdrawal Date
18-Feb-2024
ICS
11.040.25 - Syringes, needles an catheters
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
19-Feb-2024
Due Date
13-Mar-2024
Completion Date
19-Feb-2024
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
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)

Relations

Replaced By
SIST EN ISO 10555-1:2024 - Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023)
Effective Date
01-Mar-2024
Amends
SIST 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
01-Feb-2018

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EN ISO 10555-1:2013/A1:2018
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Standards Content (Sample)

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
2

---------------------- Page: 4 ----------------------

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,
...

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