ISO 20417:2021
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ISO 20417:2021
67943

Abstract  Preview

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 

  •  :  Published
     : 2021-04
     : 2021-12
     : 2021-12
  •  : 1
     : 72
  •  : ISO/TC 210 Quality management and corresponding general aspects for medical devices
  •  :
    11.040.01 Medical equipment in general

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

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