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ISO 20417:2026

Medical devices — Information to be supplied by the manufacturer

Edition date: 2026-03-17
In Force
Available languages: French, English
Summary:

NOTE 1        There is guidance or rationale for this Clause in A.2.1.

This document specifies the requirements for information supplied by the manufacturer for a medical device or 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.



NOTE 1        Des recommandations ou justifications concernant le présent article sont données au A.2.1.

Le présent document spécifie les exigences relatives aux informations fournies par le fabricant pour un dispositif médical ou un accessoire, tel que défini en 3.1. Le présent document contient les exigences génériques communes applicables concernant l'identification et l'étiquetage d'un dispositif médical ou d'un accessoire, l'emballage, le marquage d'un dispositif médical ou d'un accessoire et les informations d'accompagnement. Le présent document ne spécifie pas le mode de transmission des informations à fournir.

NOTE 2        Certaines autorités compétentes imposent des exigences différentes concernant l'identification, le marquage et la documentation d'un dispositif médical ou d'un accessoire.

Les exigences spécifiques des normes de produit ou des normes de groupe relatives à un dispositif médical prévalent sur les exigences du présent document.
ICS: 11.040.01-Medical equipment in general
CTN: ISO/TC 210 - 54892

Standards Cancellations

Anula a ISO 20417:2021

International Equivalence

Identic PNE-prEN ISO 20417

Normas Conjuntas

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