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EN ISO 21534:2009

(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)

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
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

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 21534:2009
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
SIST EN ISO 21534:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 21534:2009

---------------------- Page: 2 ----------------------

SIST EN ISO 21534:2009
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.

---------------------- Page: 3 ----------------------

SIST EN ISO 21534:2009
EN ISO 21534:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

---------------------- Page: 4 ----------------------

SIST EN ISO 21534:2009
EN ISO 21534:2009 (E)
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
...

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