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EN ISO 21535:2009/A1:2016

(Amendment)

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants - Amendment 1 (ISO 21535:2007/Amd 1:2016)

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants - Amendment 1 (ISO 21535:2007/Amd 1:2016)

2019-03-19 - JO: standard offered for citation but not cited because the amendement does not have any annex Z. TC contacted for follow-up action.

Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen an Implantate für den Hüftgelenkersatz - Änderung 1 (ISO 21535:2007/Amd 1:2016)

Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation de la hanche - Amendement 1 (ISO 21535:2007/Amd 1:2016)

Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za umetni kolk - Dopolnilo A1 (ISO 21535:2007/Amd 1:2016)

General Information

Status
Published
Publication Date
06-Dec-2016
Withdrawal Date
29-Jun-2017
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 285 - Non-active surgical implants
Drafting Committee
CEN/TC 285 - Non-active surgical implants
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
07-Dec-2016
Completion Date
07-Dec-2016
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
Ref Project
SIST EN ISO 21535:2009/A1:2017 - Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants - Amendment 1 (ISO 21535:2007/Amd 1:2016)

Relations

Amends
EN ISO 21535:2009 - Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
Effective Date
05-Dec-2014
Revised
FprEN ISO 21535 - Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO/FDIS 21535:2023)
Effective Date
18-Jan-2023

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 21535:2009/A1:2017
01-februar-2017
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za
umetni kolk - Dopolnilo A1 (ISO 21535:2007/Amd 1:2016)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-
joint replacement implants - Amendment 1 (ISO 21535:2007/Amd 1:2016)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen an Implantate für den Hüftgelenkersatz - Änderung 1 (ISO
21535:2007/Amd 1:2016)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
spécifiques relatives aux implants de remplacement de l'articulation de la hanche -
Amendement 1 (ISO 21535:2007/Amd 1:2016)
Ta slovenski standard je istoveten z: EN ISO 21535:2009/A1:2016
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 21535:2009/A1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21535:2009/A1:2017

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SIST EN ISO 21535:2009/A1:2017


EN ISO 21535:2009/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

December 2016
EUROPÄISCHE NORM
ICS 11.040.40
English Version

Non-active surgical implants - Joint replacement implants -
Specific requirements for hip-joint replacement implants -
Amendment 1 (ISO 21535:2007/Amd 1:2016)
Implants chirurgicaux non actifs - Implants de Nichtaktive chirurgische Implantate - Implantate zum
remplacement d'articulation - Exigences spécifiques Gelenkersatz - Besondere Anforderungen an
relatives aux implants de remplacement de Implantate für den Hüftgelenkersatz - Änderung 1 (ISO
l'articulation de la hanche - Amendement 1 (ISO 21535:2007/Amd 1:2016)
21535:2007/Amd 1:2016)
This amendment A1 modifies the European Standard EN ISO 21535:2009; it was approved by CEN on 14 October 2016.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21535:2009/A1:2016 E
worldwide for CEN national Members.

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SIST EN ISO 21535:2009/A1:2017
EN ISO 21535:2009/A1:2016 (E)
Contents Page
European foreword . 3
Annex ZB (informative) Correlations between undated normative references and dated EN
and ISO standards . 4

2

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SIST EN ISO 21535:2009/A1:2017
EN ISO 21535:2009/A1:2016 (E)
European foreword
This document (EN ISO 21535:2009/A1:2016) has been prepared by Technical Committee ISO/TC 150
“Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical
implants” the secretariat of which is held by DIN
This Amendment to the European Standard EN ISO 21535:2009 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by June 2017, and
conflicting national standards shall be withdrawn at the latest by June 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] 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 an
...

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