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Estado : Publicado (Para revisar)

Esta norma será reemplazada por ISO/CD 20417
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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.

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Informaciones generales

  • Estado
     : Publicado
    Fecha de publicación
     : 2021-04
    Versión corregida (en)
     : 2021-12
    Versión corregida (fr)
     : 2021-12
    Etapa
    : Norma Internacional para revisar [90.92]
  • Edición
     : 1
    Número de páginas
     : 72
  • Comité Técnico :
    ISO/TC 210
    ICS :
    11.040.01 
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