Status : Published (To be revised)

This standard will be replaced by ISO/CD 20417
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Abstract

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.

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General information

  • Status
     : Published
    Publication date
     : 2021-04
    Corrected version (en)
     : 2021-12
    Corrected version (fr)
     : 2021-12
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 1
    Number of pages
     : 72
  • Technical Committee :
    ISO/TC 210
    ICS :
    11.040.01 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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