ISO 13485:1996 

Quality systems -- Medical devices -- Particular requirements for the application of ISO 9001

General information

Number of Pages:


Edition: 1 (Monolingual) ICS: 11.040.01; 03.120.10
Status: Withdrawn Stage: 95.99 (2006-09-18)
TC/SC: TC 210  

Abstract

Specifies, in conjunction with the application of ISO 9001, the quality system requirements for the design/development and, when relevant, installation and servicing of medical devices.

Revision information

Revised by: ISO 13485:2003

Corrigenda, Amendments and other parts

ISO 13485:2003

ISO 13485:2003/Cor 1:2009

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