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Norm

ISO 20417:2021

Issue date: 2021 04 13

Medical devices — Information to be supplied by the manufacturer (Corrected version 2021-12)

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 manufacture...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 72 Pages
Language:
English

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.

ISO 20417:2021
2021 04 13
Medical devices — Information to be supplied by the manufacturer (Corrected version 2021-12)
Norm