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  • BSI
    BS EN ISO 20417:2021 - TC Tracked Changes. Medical devices. Information to be supplied by the manufacturer
    Edition: 2021
    $665.57
    / user per year

Description of BS EN ISO 20417:2021 - TC 2021

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 NumberBS EN ISO 20417:2021 - TC
TitleTracked Changes. Medical devices. Information to be supplied by the manufacturer
StatusWithdrawn
Publication Date2021-05-19
DescriptorsDocuments, Technical documents, Definitions, Packaging, Medical instruments, Marking, Symbols, Identification methods, Sterile equipment, Implants (surgical), Consumer-supplier relations, Instructions for use, Safety measures, Handbooks, Hazards, Medical equipment
ICS11.040.01 Medical equipment in general, 11.120.01 Pharmaceutics in general, 01.110 Technical product documentation
CommitteeCH/210
ISBN978 0 539 17839 5
PublisherBSI
Pages190

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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