EN ISO 21536:2007

SLOVENSKI STANDARD
01-april-2008
1DGRPHãþD
SIST EN 12564:2000
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 Implante 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 21536:2007
ICS:
11.040.40
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 21536
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2007
ICS 11.040.40 Supersedes EN 12564:1998
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 16 August 2007.
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
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EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21536:2007: E
worldwide for CEN national Members.

Contents Page
Foreword.3

Foreword
This document (EN ISO 21536:2007) 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 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 March 2008, and conflicting national standards shall be withdrawn at
the latest by March 2008.
This document supersedes EN 12564:1998.
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 EC Directive(s).
For relationship with EC 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, 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 21536:2007 without any modification.
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.

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 International Standard and Directive 93/42/EEC

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
International Standard Directive 93/42/EEC
4 1, 2, 3, 4, 5, 7.1, 7.2, 9.2
5 1, 2, 3, 4, 5, 6, 7.1, 9.1, 9.2
6 1, 2, 3, 4, 7.1, 7.2, 7.3, 7.4, 8.2, 9.1, 9.2
7 1, 2, 3, 4, 5, 6, 7.1, 7.2, 7.3, 14
8 1, 2, 3, 4, 5, 7.1, 7.2, 7.3
9 3, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7, 13.3 Via ISO 14630
10 3, 5, 7.2, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7 Via ISO 14630
11 9.1, 13
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.
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
ISO 21536:2007(E)
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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 . 4
11 Information to be supplied by the manufacturer. 4
11.1 General. 4
11.2 Information supplied on the label . 4
11.3 Constructional compatibility of components . 4
11.4 Information for the patient . 4
11.5 Marking . 4
Annex A (informative) Evaluation of range of relative angular motion of components of fully
constrained total knee joint replacement implants. 5

ISO 21536:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 21536 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 4,
Bone and joint replacements.
This second edition cancels and replaces the first edition (ISO 21536:2002), which has been technically
revised.
iv © ISO 2007 – All rights reserved

ISO 21536:2007(E)
Introduction
There are three levels of International Standard dealing with non-active surgical implants. These are as
follows, with level 1 being the highest:
⎯ level 1: general requirements for non-active surgical implants and instrumentation used in association
with implants;
⎯ level 2: particular requirements for families of non-active surgical implants;
⎯ level 3: specific requirements for types of non-active surgical implant.
This International Standard is a level 3 standard and contains requirements applying specifically to knee joint
replacements. The level 1 standard contains requirements that apply to all non-active surgical implants. It also
indicates that there are additional requirements in the level 2 and level 3 standards.
The level 2 standards apply to more restricted sets or families of implants such as those designed for use in
osteosynthesis, cardiovascular surgery or joint replaceme
...