EN ISO 21535:2009/A1:2016

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
• Directive: 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: EN ISO 21535:2024 - Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

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

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.

Contents Page
European foreword . 3
Annex ZB (informative) Correlations between undated normative references and dated EN
and ISO standards . 4

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 and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
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,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 21535:2007/Amd 1:2016 has been approved by CEN as EN ISO 21535:2009/A1:2016
without any modification.
Addition of the new Annex ZB.
Annex ZB
(informative)
Correlations between undated normative references and dated EN and ISO
standards
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard "within the
meaning of Annex ZB", the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table ZB.1 — Correlations between undated normative references and dated EN and ISO
standards
Normative Equivalent dated standard
references as listed
EN ISO
in Clause 2
ISO 7206-1:2008 — ISO 7206-1:2008
ISO 7206-2:2011 — ISO 7206-2:2011
ISO 7206-4:2010 — ISO 7206-4:2010
ISO 7206-6:2013 — ISO 7206-6:2013
ISO 7206-10:2003 — ISO 7206-10:2003
ISO 14630:2012 EN/ISO 14630:2012 ISO 14630:2012
ISO 21534:2007 EN/ISO 21534:2009 ISO 21534:2007

INTERNATIONAL ISO
STANDARD 21535
Second edition
2007-10-01
AMENDMENT 1
2016-11-15
Non-active surgical implants —
Joint replacement implants —
Specific requirements for hip-joint
replacement implants
AMENDMENT 1
Implants chirurgicaux non actifs — Implants de remplacement
d’articulation — Exigences spécifiques relatives aux implants de
remplacement de l’articulation de la hanche
AMENDEMENT 1
Reference number
ISO 21
...