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Standard

ISO 20417:2021

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Nota: Ora in fase di sviluppo: ISO/DIS 20417

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Astratto

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.

Specifiche dei prodotti

  • Standard da ISO
  • Pubblicato:
  • Edizione: 1
  • Tipo di documento: IS
  • Pagine
  • Publisher ISO
  • Distributor ISO
  • ICS 11.040.01
  • International TC ISO/TC 210

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