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.
Đang xem: Iso
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.
Publication date: 2021-04
Number of pages: 72
This standard contributes to the following Sustainable Development Goal:
Good Health and Well-being
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