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Product Product ISO 20417:2021
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Description Description

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.

Standard Number Standard Number ISO 20417:2021
Title Title ISO 20417:2021 Medical devices — Information to be supplied by the manufacturer
Status Status Published
Publication Date Publication Date 13 Apr 2021
Cross References Cross References
Descriptors Descriptors
ICS ICS 11.040.01
Committee Committee ISO/TC 210 Quality management and corresponding general aspects for medical devices
Publisher Publisher PECB Store
Format Format PDF
Delivery Delivery NO
Pages Pages 72
File Size File Size KB