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CEN

EN ISO 14602:1998

(Main)

Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)

Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)

This European standard specifies particular requirements for non-active surgical implants for osteosynthesis, hereafter referred to as implants.  In addition to EN ISO 14630:1997, this standard gives particular requirements for intended performance, design attributes,  materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer.

Nichtaktive chirurgische Implantate - Implantate zur Osteosynthese - Besondere Anforderungen (ISO 14602:1998)

Diese Norm legt besondere Anforderungen für nichtaktive chirurgische Implantate zur Osteosynthese fest, die nachstehend als Implantate bezeichnet werden. Zusätzlich zur prEN 14630:1995 enthält diese Norm besondere Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und die Bereitstellung von Informationen durch den Hersteller.

Implants chirurgicaux non actifs - Implants pour ostéosynthèse - Exigences particulières (ISO 14602:1998)

La présente norme européenne prescrit les exigences particulières relatives aux implants chirurgicaux non actifs pour ostéosynthèse, appelés ci-après "implants". En complément au prEN 14630:1995,la présente norme européenne fournit des exigences particulières 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 fournies par le fabricant.

Neaktivni kirurški vsadki (implantati) - Vsadki za osteosintezo - Posebne zahteve (ISO 14602:1998)

General Information

Status
Withdrawn
Publication Date
14-May-1998
Withdrawal Date
12-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 5 - Osteosynthesis
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
13-May-2009
Completion Date
13-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 14602:2000 - Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)

Relations

Replaced By
EN ISO 14602:2009 - Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)
Effective Date
22-Dec-2008

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EN ISO 14602:2000EN ISO 14602:2000
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SLOVENSKI STANDARD
SIST EN ISO 14602:2000
01-januar-2000
Neaktivni kirurški vsadki (implantati) - Vsadki za osteosintezo - Posebne zahteve
(ISO 14602:1998)
Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO
14602:1998)
Nichtaktive chirurgische Implantate - Implantate zur Osteosynthese - Besondere
Anforderungen (ISO 14602:1998)
Implants chirurgicaux non actifs - Implants pou
...

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