EN ISO 21534:2009

Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant".
ISO 21534:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.

Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen (ISO 21534:2007)

Diese Internationale Norm legt besondere Anforderungen an Implantate für den totalen oder partiellen
Gelenkersatz, für künstliche Bänder und für Knochenzement fest, die im Folgenden als Implantate bezeichnet
werden. Für die Anwendung dieser Internationalen Norm werden künstliche Bänder und die zu ihnen
gehörenden Befestigungsmittel in den Begriff „Implantate“ eingeschlossen.
Sie legt Anforderungen an die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung,
Herstellung, Sterilisation, Verpackung und Bereitstellung von Informationen durch den Hersteller fest.
Einige, zum Nachweis der Übereinstimmung mit dieser Internationalen Norm erforderlichen Prüfungen, sind in
den Normen der Ebene 3 enthalten oder dort als Verweise angeführt.

Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences particulières (ISO 21534:2007)

L'ISO 21534:2007 spécifie les exigences particulières relatives aux implants de remplacement total et partiel des articulations, aux ligaments artificiels, au ciment pour os, désignés «implants» ci-après. Pour les besoins de la présente Norme internationale, le terme «implant» englobe les ligaments artificiels et les dispositifs de fixation qui y sont associés, désignés ci-après «implants».
L'ISO 21534:2007 fournit des exigences relatives aux performances prévues, à la conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations devant être fournies par le fabricant.

Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve (ISO 21534:2007)

General Information

• Status: Published
• Publication Date: 05-May-2009
• Withdrawal Date: 20-Mar-2010
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285/WG 4 - Joint replacement and tools and accessories
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 06-May-2009
• Completion Date: 06-May-2009
• 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 21534:2009 - Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

Relations

• Replaces: EN ISO 21534:2007 - Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
• Effective Date: 13-May-2009

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 21534:2008
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve (ISO
21534:2007)
Non-active surgical implants - Joint replacement implants - Particular requirements (ISO
21534:2007)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen (ISO 21534:2007)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
particulières (ISO 21534:2007)
Ta slovenski standard je istoveten z: EN ISO 21534:2009
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.

EUROPEAN STANDARD
EN ISO 21534
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 21534:2007
English Version
Non-active surgical implants - Joint replacement implants -
Particular requirements (ISO 21534:2007)
Implants chirurgicaux non actifs - Implants de Nichtaktive chirurgische Implantate - Implantate zum
remplacement d'articulation - Exigences particulières (ISO Gelenkersatz - Besondere Anforderungen (ISO
21534:2007) 21534:2007)
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 21534:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

Foreword
The text of ISO 21534:2007 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 21534:2009 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 21534:2007.
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 21534:2007 has been approved by CEN as a EN ISO 21534:2009 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 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.
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, 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.
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.
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.
9 3, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7, 13.3 The part 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
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 All clauses supplement and are dependent on the corresponding clauses of EN 14630

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 21534
Second edition
2007-10-01
Non-active surgical implants — Joint
replacement implants — Particular
requirements
Implants chirurgicaux non actifs — Implants de remplacement
d'articulation — Exigences particulières

Reference number
ISO 21534:2007(E)
©
ISO 2007
ISO 21534:2007(E)
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ISO 21534:2007(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Intended performance . 2
5 Design attributes. 3
5.1 General. 3
5.2 Surface finish of metallic or ceramic implants articulating on ultra-high-molecular-weight
polyethylene (UHMWPE) . 3
5.3 Surface finish of metallic or ceramic partial implants . 3
5.4 Surfaces of convex, spherically-conforming metallic or ceramic implants articulating on
UHMWPE. 3
5.5 Surfaces of spherically-conforming metallic or ceramic partial implants. 3
5.6 Surfaces of concave, spherically-conforming UHMWPE components. 3
6 Materials . 4
6.1 General. 4
6.2 Dissimilar metals or alloys . 4
7 Design evaluation . 4
7.1 General. 4
7.2 Preclinical evaluation . 4
7.3 Clinical investigation. 5
7.4 Post market surveillance . 5
8 Manufacture and inspection . 5
8.1 General. 5
8.2 Metal surfaces . 5
8.3 Plastic surfaces. 5
8.4 Ceramic surfaces. 5
9 Sterilization. 6
9.1 General.
...