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
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Estado: PublicadoFecha de publicación: 2021-04
Versión corregida (en): 2021-12
Versión corregida (fr): 2021-12Etapa: Norma Internacional para revisar [90.92] -
Edición: 1Número de páginas: 72
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Comité Técnico :ISO/TC 210ICS :11.040.01
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Ciclo de vida
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Ahora
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Será reemplazada por
En desarrolloISO/DIS 20417
