NF EN 45502-1
NF EN 45502-1

NF EN 45502-1

May 2016
Standard Current

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Le présent document spécifie les exigences généralement applicables aux DISPOSITIFS MEDICAUX IMPLANTABLES ACTIFS. Le présent document entre dans le champ d''application de la Directive n° 90/385/CEE du 20/06/1990 concernant le rapprochement des législations des Etats membres relatives aux dispositifs médicaux implantables actifs.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2016

Number of pages

75 p.

Reference

NF EN 45502-1

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics
11.040.60   Therapy equipment

Print number

1

European kinship

EN 45502-1:2015
Sumary
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Le présent document spécifie les exigences généralement applicables aux DISPOSITIFS MEDICAUX IMPLANTABLES ACTIFS. Le présent document entre dans le champ d''application de la Directive n° 90/385/CEE du 20/06/1990 concernant le rapprochement des législations des Etats membres relatives aux dispositifs médicaux implantables actifs.
Replaced standards (1)
NF EN 45502-1
NF EN 45502-1
November 1998
Standard Cancelled
Active implantable medical devices. Part 1 : general requirements for safety, marking and information to be provided by the manufacturer.

Cette partie 1 de l'EN 45502 spécifie les exigences généralement applicables aux DISPOSITIFS MÉDICAUX IMPLANTABLES ACTIFS. Les exigences essentielles relatives à des types spéciaux de DISPOSITIFS MÉDICAUX IMPLANTABLES ACTIFS sont complétées ou modifiées par les exigences des normes particulières, qui sont regroupées dans les parties additionnelles de cette norme.

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