NF EN ISO 20417
NF EN ISO 20417

NF EN ISO 20417

May 2021
Standard Cancelled

Medical devices — Information to be supplied by the manufacturer

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Main informations

Collections

National standards and national normative documents

Publication date

May 2021

Number of pages

92 p.

Reference

NF EN ISO 20417

ICS Codes

01.110   Technical product documentation
11.040.01   Medical equipment in general

Print number

2 - janvier 2023

International kinship

ISO 20417:2021

European kinship

EN ISO 20417:2021
Replaced standards (1)
NF EN 1041+A1
NF EN 1041+A1
November 2013
Standard Cancelled
Information supplied by the manufacturer of medical devices

Le présent document spécifie les exigences concernant les informations à fournir par un fabricant de dispositifs médicaux d'après la réglementation dictée par la Directive du Conseil 90/385/CE relative aux dispositifs médicaux implantables actifs et par la Directive du Conseil 93/42/CE concernant les dispositifs médicaux. Il ne spécifie pas la langue à utiliser pour ces informations ni les moyens par lesquels les informations sont fournies. Il a également pour but de venir compléter les exigences spécifiques des Directives UE sur les dispositifs médicaux citées en donnant des indications sur la manière dont certaines exigences peuvent être satisfaites. Si un fabricant suit ces indications, celles-ci laissent à présumer de la conformité aux exigences essentielles relatives à la fourniture d'informations.

Standard replaced by (1)
NF EN ISO 20417
NF EN ISO 20417
April 2026
Standard Current
Medical devices - Information to be supplied by the manufacturer

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