SIST EN ISO 21535:2009

SLOVENSKI STANDARD
SIST EN ISO 21535:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 21535:2008
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za
umetni kolk (ISO 21535:2007)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-
joint replacement implants (ISO 21535:2007)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2007)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
spécifiques relatives aux implants de remplacement de l'articulation de la hanche (ISO
21535:2007)
Ta slovenski standard je istoveten z: EN ISO 21535:2009
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 21535:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21535:2009

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SIST EN ISO 21535:2009
EUROPEAN STANDARD
EN ISO 21535
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 21535:2007
English Version
Non-active surgical implants - Joint replacement implants -
Specific requirements for hip-joint replacement implants (ISO
21535:2007)
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 de den Hüftgelenkersatz (ISO 21535:2007)
la hanche (ISO 21535:2007)
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 21535:2009: E
worldwide for CEN national Members.

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SIST EN ISO 21535:2009
EN ISO 21535:2009 (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 21535:2009
EN ISO 21535:2009 (E)
Foreword
The text of ISO 21535:2007 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 21535:2009 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 21535:2007.
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 21535:2007 has been approved by CEN as a EN ISO 21535:2009 without any modification.
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SIST EN ISO 21535:2009
EN ISO 21535:2009 (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- Essential Requirements (ERs) of Qualifying remarks/Notes
clause(s) of this EN 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, 9.1, The part of ER 1 relating to the risk of
9.2 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.
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.
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SIST EN ISO 21535:2009
EN ISO 21535:2009 (E)

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, 13.3 Via ISO 14630
The modification of ER 13.3 f is not
addressed in this European Standard.
10 3, 5, 7.2, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7 Via ISO 14630
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.
ER 13.3 f is only partly addressed in
this European Standard: safety issue of
single use.
ER 13.6 q is not addressed by this
International 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 21535:2009

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SIST EN ISO 21535:2009

INTERNATIONAL ISO
STANDARD 21535
Second edition
2007-10-01

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




Reference number
ISO 21535:2007(E)
©
ISO 2007

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SIST EN ISO 21535:2009
ISO 21535:2007(E)
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ii © ISO 2007 – All rights reserved

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SIST EN ISO 21535:2009
ISO 21535:2007(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. 3
5.1 General. 3
5.2 Tolerances and dimensions . 3
5.3 Thickness of UHMWPE in acetabular components and bipolar heads. 3
6 Materials . 3
7 Design evaluation . 4
7.1 General. 4
7.2 Preclinical evaluation . 4
8 Manufacture. 4
9 Sterilization. 5
10 Packaging . 5
11 Information to be supplied by the manufacturer. 5
11.1 General. 5
11.2 Dimensions. 5
11.3 Structural and functional compatibility of components. 5
11.4 Marking . 5
11.5 Information for the patient . 6
Annex A (informative) Evaluation of relative angular motion of components. 7
Bibliography . 9

© ISO 2007 – All rights reserved iii

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SIST EN ISO 21535:2009
ISO 21535:2007(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 21535 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 21535:2002), which has been technically
revised.
iv © ISO 2007 – All rights reserved

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SIST EN ISO 21535:2009
ISO 21535:2007(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-ac
...