Status : Under development

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.

General information

  • Status
     : Under development
    Stage
    : CD approved for registration as DIS [30.99]
  • Edition
     : 2
  • Technical Committee :
    ISO/TC 210
    ICS :
    11.040.01 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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