UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close

This is embarrasing..

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing..

An error occurred while processing the form. Please try again in a few minutes.

ISO FDIS 20417

Medical devices — Information to be supplied by the manufacturer

active, Most Current
Buy Now
Organization: ISO
Publication Date: 3 April 2020
Status: active
Page Count: 82
ICS Code (Medical equipment in general): 11.040.01
scope:

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, their 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 Some authorities with 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.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.

Document History

ISO FDIS 20417
April 3, 2020
Medical devices — Information to be supplied by the manufacturer
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...

References

Advertisement