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SIST EN ISO 14602:2000

(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 ostéosynthese - Exigences particulieres (ISO 14602:1998)

La présente norme européenne prescrit les exigences particulieres relatives aux implants chirurgicaux non actifs pour ostéosynthese, appelés ci-apres "implants". En complément au prEN 14630:1995,la présente norme européenne fournit des exigences particulieres relatives aux performances prévues, a la conception, aux matériaux, a l'évaluation de la conception, a la fabrication, a la stérilisation, a 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Withdrawn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
31-Dec-1999
Withdrawal Date
24-May-2009
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
25-May-2009
Due Date
17-Jun-2009
Completion Date
25-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
EN ISO 14602:1998 - Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)

Relations

Replaced By
SIST EN ISO 14602:2009 - Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)
Effective Date
01-Jul-2009
Replaced By
SIST EN ISO 14602:2009 - Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)
Effective Date
08-Jun-2022

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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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