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ISO 20417:2021

Medical devices — Information to be supplied by the manufacturer

Apr 13, 2021

General information

90.92     Dec 18, 2023

ISO

ISO/TC 210

International Standard

11.040.01  

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Published

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Scope

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.

Life cycle

NOW

PUBLISHED
ISO 20417:2021
90.92 Standard to be revised
Dec 18, 2023

REVISED BY

IN_DEVELOPMENT
ISO/DIS 20417