NF EN ISO 20417

NF EN ISO 20417

May 2021
Standard Current

Medical devices - Information to be provided by the manufacturer

NOTE 1        There is guidance or rationale for this Clause contained in Clause A.2.This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.NOTE 2        Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2021

Number of pages

86 p.

Reference

NF EN ISO 20417

ICS Codes

01.110   Technical product documentation
11.040.01   Medical equipment in general

Classification index

S99-001

Print number

2 - 01/01/2023

International kinship

ISO 20417:2021

European kinship

EN ISO 20417:2021
Sumary
Medical devices - Information to be provided by the manufacturer

NOTE 1        There is guidance or rationale for this Clause contained in Clause A.2.

This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.

NOTE 2        Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.

Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

Replaced standards (1)
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.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Considérations générales
  • 5 Éléments informatifs à définir
  • 6 Exigences relatives aux informations d'accompagnement
  • 7 Autres informations devant être fournies avec le dispositif médical ou l' accessoire
  • Annexe A (informative) Recommandations et justifications particulières
  • Annexe B (informative) Exemple de méthode d'essai pour évaluer des exigencesclairement lisibles
  • Annexe C (informative) Exemple de méthode d'essai pour évaluer la durabilité
  • Annexe D (informative) Référence croisée entre le document et les exigences prises en compte
  • Annexe E (informative) Référence auxprincipes essentielsde l'IMDRF et aux recommandations pour l'étiquetage
  • Annexe F (informative) Référence auxprincipes essentiels
  • Annexe G (informative) Référence aux exigences en matière de sécurité et de performance pour lesdispositifs médicaux
  • Annexe H (informative) Référence aux exigences en matière de sécurité et de performance pour lesdispositifs médicaux de DIV
  • Annexe 1 (informative) Terminologie - Index alphabétique des termes définis
  • Bibliographie
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