EN 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

• Status: Withdrawn
• Publication Date: 14-Sep-2007
• Withdrawal Date: 05-May-2009
• 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: 9960 - Withdrawal effective - Withdrawal
• Start Date: 06-May-2009
• Completion Date: 06-May-2009
• 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 21534:2008 - Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

Relations

• Replaces: EN 12010:1998 - Non-active surgical implants - Joint replacement implants - Particular requirements
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 21534:2009 - Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
• Effective Date: 13-May-2009

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



EN ISO 21534:2007 (E) 2 Contents Page Foreword.3



EN ISO 21534:2007 (E) 3 Foreword This document (EN ISO 21534:2007) 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 12010:1998. 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 21534:2007 has been approved by CEN as a EN ISO 21534:2007 without any modification.



EN ISO 21534:2007 (E) 4
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-cl
...