EN ISO 21535:2007
(Main)Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
This International Standard provides specific requirements for hip 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 Hüftgelenkersatz (ISO 21535:2007)
Diese Internationale Norm legt besondere Anforderungen an Implantate für den Hüftgelenkersatz fest. Unter Berücksichtigung der Sicherheit legt diese Internationale Norm Anforderungen an die vorgesehene Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung, die Bereitstellung von Informationen durch den Hersteller und Prüfverfahren fest.
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)
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za umetni kolk (ISO 21535:2007)
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za umetni kolk (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)Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2007)Ta slovenski standard je istoveten z:EN ISO 21535:2007SIST EN ISO 21535:2008en11.040.40ICS:SIST EN 12563:20001DGRPHãþDSLOVENSKI
STANDARDSIST EN ISO 21535:200801-april-2008
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 21535September 2007ICS 11.040.40Supersedes EN 12563:1998
English VersionNon-active surgical implants - Joint replacement implants -Specific requirements for hip-joint replacement implants (ISO21535:2007)Implants chirurgicaux non actifs - Implants deremplacement d'articulation - Exigences spécifiquesrelatives aux implants de remplacement de l'articulation dela hanche (ISO 21535:2007)Nichtaktive chirurgische Implantate - Implantate zumGelenkersatz - Besondere Anforderungen an Implantate fürden Hüftgelenkersatz (ISO 21535:2007)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 EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2007 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 21535:2007: 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.
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 International Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 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.
Reference numberISO 21534:2007(E)© ISO 2007
INTERNATIONAL STANDARD ISO21534Second edition2007-10-01Non-active surgical implants — Joint replacement implants — Particular requirements Implants chirurgicaux non actifs — Implants de remplacement d'articulation — Exigences particulières
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ii © ISO 2007 – All rights reserved
ISO 21534:2007(E) © ISO 2007 – All rights reserved iiiContents 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.6 9.2 Expiry.6 10 Packaging.6 11 Information supplied by the manufacturer.6 11.1 General.6 11.2 Labelling of implants for use on one side of the body only.6 11.3 Instructions for orientation of implants.6 11.4 Markings for orientation of the implants.6 11.5 Placing of markings on implants.6 11.6 Restrictions on use.7 11.7 Re-sterilization of zirconia ceramics.7 11.8 Labelling of implants for use with or without bone cement.7 Annex A (informative)
List of International Standards for materials found acceptable for the manufacture of implants.8 Annex B (informative)
List of International Standards for materials found acceptable or not acceptable for articulating surfaces of implants.9
ISO 21534:2007(E) iv © ISO 2007 – All rights reserved Annex C (informative)
List of materials found acceptable or non-acceptable for metallic combinations for non-articulating contacting surfaces of implants.11 Bibliography.12
ISO 21534:2007(E) © ISO 2007 – All rights reserved vForeword 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
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