EN ISO 14630:2009
(Main)Non-active surgical implants - General requirements (ISO 14630:2008)
Non-active surgical implants - General requirements (ISO 14630:2008)
ISO 14630:2008 specifies general requirements for non-active surgical implants. ISO 14630:2008 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.
With regard to safety, ISO 14630:2008 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards.
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2008)
Diese Internationale Norm legt allgemeine Anforderungen für nichtaktive chirurgische Implantate fest, im
Folgenden Implantate genannt. Diese Internationale Norm gilt nicht für Dentalimplantate, dentalrestaurative
Werkstoffe, transendodontische und transradikuläre Implantate, Intraokularlinsen sowie Implantate, die
lebensfähige tierische Gewebe nutzen.
In Bezug auf die Sicherheit legt diese Internationale Norm Anforderungen für die beabsichtigte Funktion,
Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und die Bereitstellung
von Informationen durch den Hersteller sowie Prüfverfahren fest, um die Übereinstimmung mit diesen
Anforderungen zu zeigen. Zusätzliche Prüfverfahren sind enthalten in Normen der Ebene 2 und 3 bzw. es
finden sich darin Verweise hierauf.
ANMERKUNG Diese Internationale Norm fordert vom Hersteller kein Qualitätsmanagementsystem. Dennoch könnte
die Anwendung eines wie in ISO 13485 beschriebenen Qualitätsmanagementsystems zur Unterstützung der Gewährleistung
angemessen sein, dass das Implantat die beabsichtigte Funktion erfüllt.
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2008)
L'ISO 14630:2008 spécifie des exigences générales relatives aux implants chirurgicaux non actifs. Elle ne s'applique ni aux implants dentaires, ni aux produits utilisés en médecine dentaire restauratrice, ni aux implants transendodontiques et transradiculaires, ni aux lentilles intraoculaires, ni aux implants utilisant des tissus animaux viables.
En matière de sécurité, l'ISO 14630:2008 fournit des exigences relatives aux performances prévues, aux caractéristiques de conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations fournies par le fabricant, de même qu'aux essais destinés à faire la preuve de la conformité à ces exigences. Des essais supplémentaires ou leurs références sont indiqués dans les normes de niveau 2 et de niveau 3.
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2008)
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2008)Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2008)Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2008)Non-active surgical implants - General requirements (ISO 14630:2008)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN ISO 14630:2009SIST EN ISO 14630:2009en01-julij-2009SIST EN ISO 14630:2009SLOVENSKI
STANDARDSIST EN ISO 14630:20081DGRPHãþD
SIST EN ISO 14630:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 14630May 2009ICS 11.040.40Supersedes EN ISO 14630:2008
English VersionNon-active surgical implants - General requirements (ISO14630:2008)Implants chirurgicaux non actifs - Exigences générales(ISO 14630:2008)Nichtaktive chirurgische Implantate - AllgemeineAnforderungen (ISO 14630:2008)This European Standard was approved by CEN on 19 April 2009.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:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 14630:2009: ESIST EN ISO 14630:2009
EN ISO 14630:2009 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC .4 SIST EN ISO 14630:2009
EN ISO 14630:2009 (E) 3 Foreword The text of ISO 14630:2008 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 14630:2009 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 14630:2008. 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. For relationship with EC 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 14630:2008 has been approved by CEN as a EN ISO 14630:2009 without any modification. SIST EN ISO 14630:2009
EN ISO 14630:2009 (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 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.
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