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CEN

EN ISO 14630:1997

(Main)

Non-active surgical implants - General requirements (ISO 14630:1997)

Non-active surgical implants - General requirements (ISO 14630:1997)

This European Standard specifies general requirements for non-active surgical implants.  This standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses.  With regard to safety, this standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests.  Tests required to be used to demonstrate compliance with this standard are contained in other levels.

Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:1997)

Diese Europäische Norm legt allgemeine Anforderungen für nichtaktive chirurgische Implantate fest. Diese Norm gilt nicht für Dentalimplantate, transendodontische und transradikuläre Implantate sowie Intraokularlinsen. In Bezug auf die Sicherheit legt diese Norm Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und die Bereitstellung von Informationen durch den Hersteller sowie Prüfverfahren fest.

Implants chirurgicaux non actifs - Exigences générales (ISO 14630:1997)

La présente norme européenne spécifie les 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 et ne concerne pas non plus verres intraoculaires.

Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:1997)

General Information

Status
Withdrawn
Publication Date
31-Oct-1997
Withdrawal Date
30-Apr-2005
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 1 - General requirements for non active surgical implants
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
01-May-2005
Completion Date
01-May-2005
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 14630:2000 - Non-active surgical implants - General requirements (ISO 14630:1997)

Relations

Child
EN 12011:1998 - Instrumentation to be used in association with non-active surgical implants - General requirements
Effective Date
22-Dec-2008
Replaced By
EN ISO 14630:2005 - Non-active surgical implants - General requirements (ISO 14630:2005)
Effective Date
22-Dec-2008

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EN ISO 14630:2000EN ISO 14630:2000
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EN ISO 14630:2000
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14630:2000
01-januar-2000
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:1997)
Non-active surgical implants - General requirements (ISO 14630:1997)
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:1997)
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:1997)
Ta slovenski standard je istoveten z: EN ISO 14630:1997
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 14630:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14630:2000

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SIST EN ISO 14630:2000

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SIST EN ISO 14630:2000

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SIST EN ISO 14630:2000

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SIST EN ISO 14630:20
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