文档介绍：INTERNATIONAL ISO
STANDARD 13485
Second edition
2003-07-15
Medical devices — Quality management
systems — Requirements for regulatory
purposes
Dispositifs médicaux — Systèmes de management de la qualité —
Exigences à des fins réglementaires
Reference number
ISO 13485:2003(E)
© ISO 2003
ISO 13485:2003(E)
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ISO 13485:2003(E)
Contents Page
Foreword.............................................................................................................................................