EN ISO 21534:2007
(Main)Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant". It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer. Some tests required to demonstrate conformance to this International Standard are contained in or referenced in level 3 standards.
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen (ISO 21534:2007)
Diese Internationale Norm legt besondere Anforderungen an Implantate für den totalen oder partiellen Gelenk¬ersatz, 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)
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve (ISO 21534:2007)
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve (ISO 21534:2007)Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences particulieres (ISO 21534:2007)Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen (ISO 21534:2007)Ta slovenski standard je istoveten z:EN ISO 21534:2007SIST EN ISO 21534:2008en11.040.40ICS:SIST EN 12010:20001DGRPHãþDSLOVENSKI
STANDARDSIST EN ISO 21534:200801-april-2008
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 21534September 2007ICS 11.040.40Supersedes EN 12010:1998
English VersionNon-active surgical implants - Joint replacement implants -Particular requirements (ISO 21534:2007)Implants chirurgicaux non actifs - Implants deremplacement d'articulation - Exigences particulières (ISO21534:2007)Nichtaktive chirurgische Implantate - Implantate zumGelenkersatz - Besondere Anforderungen (ISO21534:2007)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 21534:2007: 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 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.1 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
10 3, 5, 7.2, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7
11 9.1, 13
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.
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 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
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