ISO 20417:2021

Medical devices -- Information to be supplied by the manufacturer
Autor: ISO
Código ICS: 11.040.01


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.

Especificaciones de la Norma
Fecha de Publicación 13/04/2021
Título Secundario Dispositifs médicaux -- Informations à fournir par le fabricant
Páginas Técnicas 72
Idioma Inglés