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Homepage>BS Standards>01 GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION>01.110 Technical product documentation>BS EN ISO 20417:2021 Medical devices. Information to be supplied by the manufacturer
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BS EN ISO 20417:2021 Medical devices. Information to be supplied by the manufacturer

BS EN ISO 20417:2021

Medical devices. Information to be supplied by the manufacturer

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Standard number:BS EN ISO 20417:2021
Pages:86
Released:2022-05-27
ISBN:978 0 539 22260 9
Status:Corrigendum
DESCRIPTION

BS EN ISO 20417:2021


This standard BS EN ISO 20417:2021 Medical devices. Information to be supplied by the manufacturer is classified in these ICS categories:
  • 11.040.01 Medical equipment in general
  • 11.120.01 Pharmaceutics in general
  • 01.110 Technical product documentation
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.