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ISO 13485:2016

ISO 13485:2016

Medical devices — Quality management systems — Requirements for regulatory purposes

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

Date:
2016-02-25 / Published
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.

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

Anula a: ISO 13485:2003/Cor 1:2009

Anula a: ISO 13485:2003

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This standard is available in:

Digital format

Ingles / Frances