ISO/CD 20417
Medical devices — Information to be supplied by the manufacturer
Reference number
ISO/CD 20417
Edición 2
Committee Draft
ISO/CD 20417
88714
El comité está revisando un borrador.
Reemplazará ISO 20417:2021

Resumen

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.

Informaciones generales

  •  : En desarrollo
    : CD aprobado para su registro como DIS [30.99]
  •  : 2
  • ISO/TC 210
    11.040.01 
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