SS-EN-ISO-20417 › Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
SS-EN-ISO-20417
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2021 EDITION
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CURRENT
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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.
To find similar documents by classification:
11.040.01 (Medical equipment in general)
Active implantable medical devices. Medical devices. In vitro diagnostic medical devices
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Designation Name
SS-EN ISO 20417:2021
Revision Level
2021 EDITION
Status
Current
Publication Date
May 10, 2021
Language(s)
English
Page Count
84
International Equivalent
EN ISO 20417:2021(IDT); ISO 20417:2021(IDT)