Abstract
NOTEÂ 1Â Â Â Â Â Â Â 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.
NOTEÂ 2Â Â Â Â Â Â Â 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.
General information
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Status: PublishedPublication date: 2021-04
Corrected version (en): 2021-12
Corrected version (fr): 2021-12Stage: International Standard to be revised [90.92] -
Edition: 1Number of pages: 72
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Technical Committee :Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 210ICS :11.040.01
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Life cycle
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Now
PublishedÏã¸ÛÁùºÏ²Ê¿ª½± 20417:2021
A standard is reviewed every 5 years
Stage: 90.92 (To be revised) -
Will be replaced by
Under developmentÏã¸ÛÁùºÏ²Ê¿ª½±/CD 20417
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