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ISO 13485:2003

ISO 13485:2003

Medical devices — Quality management systems — Requirements for regulatory purposes

Dispositifs médicaux — Systèmes de management de la qualité — Exigences à des fins réglementaires

Fecha Anulación:
2003-07-03 / Withdrawn
ICS:

03.100.70 - Management systems. Including environmental management systems (EMS), road traffic management systems, energy management systems, health care management systems, etc.

11.040.01 - Medical equipment in general.

Comité:
ISO/TC 210 - Quality management and corresponding general aspects for medical devices
Relación con otras normas ISO:

Anula a: ISO 13485:1996

Es modificada por: ISO 13485:2003/Cor 1:2009

Es anulada por: ISO 13485:2016

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Ingles / Frances