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ISO 20417:2021

Current
Current

The latest, up-to-date edition.

Medical devices — Information to be supplied by the manufacturer
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

04-13-2021

NOTE1 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.

NOTE2 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.

Committee
ISO/TC 210
DocumentType
Standard
Pages
72
ProductNote
This standard also refers to IEC 60417, IMDRF/GRRP WG/N472018, IMDRF/GRRP WG/N52 2019, IMDRF/UDI WG/N7 2013, Council directive 90/385/EEC, Council directive 93/42/EEC, Council directive 98/79/EC
PublisherName
International Organization for Standardization
Status
Current

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