SIST EN ISO 21536:2009/A1:2014

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1 (ISO 21536:2007/Amd 1:2014)

This International Standard provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.

Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen an Implantate für den Kniegelenkersatz - Änderung 1 (ISO 21536:2007/Amd 1:2014)

N/A

Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation du genou - Amendement 1 (ISO 21536:2007/Amd 1:2014)

Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za kolenske proteze - Dopolnilo A1 (ISO 21536:2007/Amd 1:2014)

Ta mednarodni standard navaja posebne zahteve za kolenske proteze. V zvezi z varnostjo ta mednarodni standard določa zahteve za predvidene lastnosti, obliko, materiale, vrednotenje oblike, izdelavo, sterilizacijo, pakiranje in informacije, ki jih zagotovi proizvajalec, ter preskusne metode.

General Information

• Status: Published
• Public Enquiry End Date: 19-Jun-2012
• Publication Date: 21-Apr-2014
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 09-Apr-2014
• Due Date: 14-Jun-2014
• Completion Date: 22-Apr-2014
• 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: EN ISO 21536:2009/A1:2014 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1 (ISO 21536:2007/Amd 1:2014)

Relations

• Amends: SIST EN ISO 21536:2009 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
• Effective Date: 01-May-2014
• Revised: kSIST FprEN ISO 21536:2023 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO/FDIS 21536:2023)
• Effective Date: 13-Feb-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 21536:2009/A1:2014
01-maj-2014
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za
kolenske proteze - Dopolnilo A1 (ISO 21536:2007/Amd 1:2014)
Non-active surgical implants - Joint replacement implants - Specific requirements for
knee-joint replacement implants - Amendment 1 (ISO 21536:2007/Amd 1:2014)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen an Implantate für den Kniegelenkersatz - Änderung 1 (ISO
21536:2007/Amd 1:2014)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
spécifiques relatives aux implants de remplacement de l'articulation du genou -
Amendement 1 (ISO 21536:2007/Amd 1:2014)
Ta slovenski standard je istoveten z: EN ISO 21536:2009/A1:2014
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 21536:2009/A1:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21536:2009/A1:2014

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SIST EN ISO 21536:2009/A1:2014

EUROPEAN STANDARD
EN ISO 21536:2009/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
March 2014
ICS 11.040.40
English Version
Non-active surgical implants - Joint replacement implants -
Specific requirements for knee-joint replacement implants -
Amendment 1 (ISO 21536:2007/Amd 1:2014)
Implants chirurgicaux non actifs - Implants de Nichtaktive chirurgische Implantate - Implantate zum
remplacement d'articulation - Exigences spécifiques Gelenkersatz - Besondere Anforderungen an Implantate für
relatives aux implants de remplacement de l'articulation du den Kniegelenkersatz - Änderung 1 (ISO 21536:2007/Amd
genou - Amendement 1 (ISO 21536:2007/Amd 1:2014) 1:2014)
This amendment A1 modifies the European Standard EN ISO 21536:2009; it was approved by CEN on 4 January 2014.

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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21536:2009/A1:2014 E
worldwide for CEN national Members.

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SIST EN ISO 21536:2009/A1:2014
EN ISO 21536:2009/A1:2014 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4
2

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SIST EN ISO 21536:2009/A1:2014
EN ISO 21536:2009/A1:2014 (E)
Foreword
This document (EN ISO 21536:2009/A1:2014) has been prepared by Technical Committee ISO/TC 150
"Implants for surgery" in collaboration 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 21536:2009 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by September 2014, and
conflicting national standards shall be withdrawn at the latest by September 2014.
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).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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 21536:2007/Amd 1:2014 has been approved by CEN as EN ISO 21536:2009/A1:2014 without
any modification.

3

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SIST EN ISO 21536:2009/A1:2014
EN ISO 21536:2009/A1:2014 (E)
Annex ZA
(informati
...

SLOVENSKI STANDARD
SIST EN ISO 21536:2009/oprA1:2012
01-maj-2012
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za
kolenske proteze (ISO 21536:2007/DAmd 1:2012)
Non-active surgical implants - Joint replacement implants - Specific requirements for
knee-joint replacement implants (ISO 21536:2007/DAmd 1:2012)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen an Implantate für den Kniegelenkersatz (ISO 21536:2007/DAmd 1:2012)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
spécifiques relatives aux implants de remplacement de l'articulation du genou (ISO
21536:2007/DAmd 1:2012)
Ta slovenski standard je istoveten z: EN ISO 21536:2009/prA1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 21536:2009/oprA1:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21536:2009/oprA1:2012

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SIST EN ISO 21536:2009/oprA1:2012


EUROPEAN STANDARD
DRAFT
EN ISO 21536:2009
NORME EUROPÉENNE

EUROPÄISCHE NORM
prA1
March 2012
ICS 11.040.40
English Version
Non-active surgical implants - Joint replacement implants -
Specific requirements for knee-joint replacement implants (ISO
21536:2007/DAmd 1:2012)
Implants chirurgicaux non actifs - Implants de Nichtaktive chirurgische Implantate - Implantate zum
remplacement d'articulation - Exigences spécifiques
Gelenkersatz - Besondere Anforderungen an Implantate für
relatives aux implants de remplacement de l'articulation du den Kniegelenkersatz (ISO 21536:2007/DAmd 1:2012)
genou (ISO 21536:2007/DAmd 1:2012)
This draft amendment is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee CEN/TC 285.

This draft amendment A1, if approved, will modify the European Standard EN ISO 21536:2009. If this draft becomes an amendment, 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.

This draft amendment was established by CEN 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21536:2009/prA1:2012: E
worldwide for CEN national Members.

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SIST EN ISO 21536:2009/oprA1:2012
EN ISO 21536:2009/prA1:2012 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 21536:2009/oprA1:2012
EN ISO 21536:2009/prA1:2012 (E)
Foreword
This document EN ISO 21536:2009/prA1:2012 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 document is currently submitted to the parallel Enquiry.
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.
Endorsement notice
The text of ISO 21536:2007/Damd 1:2012 has been approved by CEN as a EN ISO 21536:2009/prA1:2012
without any modification.
3

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SIST EN ISO 21536:2009/oprA1:2012

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SIST EN ISO 21536:2009/oprA1:2012

DRAFT AMENDMENT ISO 21536:2007/DAM 1
ISO/TC 150/SC 4 Secretariat: BSI
Voting begins on Voting terminates on

2012-03-08 2012-08-08
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION


Non-active surgical implants — Joint replacement implants —
Specific requirements for knee-joint replacement implants
AMENDMENT 1
Im
...