Standard Swedish standard · SS-EN ISO 20417:2021

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)

Status: Valid

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Standard Swedish standard · SS-EN ISO 20417:2021

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
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Scope
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.

Subjects

General (11.040.01)


Buy this standard

Standard Swedish standard · SS-EN ISO 20417:2021

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
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Price: 1 615 SEK
standard ikon pdf

PDF

Price: 1 615 SEK
standard ikon

Paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80029064

Edition: 1

Approved: 5/10/2021

No of pages: 84

Also available in: SS-EN ISO 20417:2021

Replaces: SS-EN 1041:2008+A1:2013 , SS-ISO 20417:2021