SIST EN ISO 21536:2009

SLOVENSKI STANDARD
SIST EN ISO 21536:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 21536:2008
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za
kolenske proteze (ISO 21536:2007)
Non-active surgical implants - Joint replacement implants - Specific requirements for
knee-joint replacement implants (ISO 21536:2007)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen an Implantate für den Kniegelenkersatz (ISO 21536:2007)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
spécifiques relatives aux implants de remplacement de l'articulation du genou (ISO
21536:2007)
Ta slovenski standard je istoveten z: EN ISO 21536:2009
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 21536:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21536:2009

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SIST EN ISO 21536:2009
EUROPEAN STANDARD
EN ISO 21536
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 21536:2007
English Version
Non-active surgical implants - Joint replacement implants -
Specific requirements for knee-joint replacement implants (ISO
21536:2007)
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)
genou (ISO 21536:2007)
This European Standard was approved by CEN on 12 April 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21536:2009: E
worldwide for CEN national Members.

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

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SIST EN ISO 21536:2009
EN ISO 21536:2009 (E)
Foreword
The text of ISO 21536:2007 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 21536:2009 by
Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
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 supersedes EN ISO 21536:2007.
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.
For relationship with EU Directive, 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, 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 and the United Kingdom.
Endorsement notice
The text of ISO 21536:2007 has been approved by CEN as a EN ISO 21536:2009 without any modification.
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SIST EN ISO 21536:2009
EN ISO 21536:2009 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
4 1, 2, 3, 4, 5, 7.1, 7.2, 9.2 The part of ER 1 relating to the
risk of use error is not addressed
in this European Standard. The
part of ER 7.1 relating to results
of biophysical and modelling
research is not addressed by
this European Standard.
5 1, 2, 3, 4, 5, 6, 7.1, 9.1, 9.2 The part of ER 1 relating to the
risk of use error is not addressed
in this European Standard. The
part of ER 7.1 relating to results
of biophysical and modelling
research is not addressed by
this European Standard.
6 1, 2, 3, 4, 7.1, 7.2, 7.3, 7.4, 8.2, The part of ER 1 relating to the
9.1, 9.2 risk of use error is not addressed
in this European Standard. The
part of ER 7.1 relating to results
of biophysical and modelling
research is not addressed by
this European Standard. The
part of ER 7.4 relating to the
regulatory provision for the
verification of the medicinal
product is not addressed in this
European Standard.
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SIST EN ISO 21536:2009
EN ISO 21536:2009 (E)

7 1, 2, 3, 4, 5, 6, 6a. , 7.1, 7.2, 7.3 The part of ER 1 relating to the
risk of use error is not addressed
in this European Standard. The
part of ER 7.1 relating to results
of biophysical and modelling
research is not addressed by
this European Standard.
8 1, 2, 3, 4, 5, 7.1, 7.2, 7.3 The part of ER 1 relating to the
risk of use error is not addressed
in this European Standard. The
part of ER 7.1 relating to results
of biophysical and modelling
research is not addressed by
this European Standard.
9 3, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7, Via ISO 14630
13.3
The part of ER 13.3.a
concerning the information on
the authorized representative is
not addressed in this European
Standard.
The ER 13.3 f is only partly
addressed in this European
Standard: safety issue of single
use.
10 3, 5, 7.2, 8.1, 8.3, 8.4, 8.5, 8.6, Via ISO 14630
8.7
11 9.1, 13 The part of ER 13.3.a
concerning the information on
the authorized representative is
not addressed in this European
Standard.
The ER 13.3 f is only partly
addressed in this European
Standard: safety issue of single
use. The part of ER 13.6.h)
relating to single use is not
addressed in this European
Standard.
ER 13.6 q is not addressed in
this European Standard.
NOTE Clauses 4, 5, 6, 7, 8 and subclause 11.5 supplement and are dependent on the
corresponding clauses of ISO 21534.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
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SIST EN ISO 21536:2009

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SIST EN ISO 21536:2009

INTERNATIONAL ISO
STANDARD 21536
Second edition
2007-10-01

Non-active surgical implants — Joint
replacement implants — Specific
requirements for knee-joint replacement
implants
Implants chirurgicaux non actifs — Implants de remplacement
d'articulation — Exigences spécifiques relatives aux implants de
remplacement de l'articulation du genou




Reference number
ISO 21536:2007(E)
©
ISO 2007

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SIST EN ISO 21536:2009
ISO 21536:2007(E)
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ii © ISO 2007 – All rights reserved

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SIST EN ISO 21536:2009
ISO 21536:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Intended performance . 2
5 Design attributes. 2
5.1 General. 2
5.2 Thickness of ultra-high molecular weight polyethylene (UHMWPE) in tibial components
and meniscal components. 2
5.3 Finish of non-articulating regions of metallic knee joint components . 3
6 Materials . 3
7 Design evaluation . 3
7.1 General. 3
7.2 Preclinical evaluation . 3
8 Manufacture. 3
9 Sterilization. 4
10 Packaging .
...