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NEN-EN-ISO 20417

Medical devices - Information to be supplied by the manufacturer

active, Most Current
Organization: NEN
Publication Date: 1 May 2021
Status: active
Page Count: 88
ICS Code (Medical equipment in general): 11.040.01
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.

Document History

NEN-EN-ISO 20417
May 1, 2021
Medical devices - Information to be supplied by the manufacturer
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...

References

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