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ISO 13485:1996
Quality systems -- Medical devices -- Particular requirements for the application of ISO 9001
This standard has been revised by: ISO 13485:2003
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.
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Edition: 1 (Monolingual) ICS: 03.120.10; 11.040.01 Status: Withdrawn Stage: 95.99 (2006-09-18) TC/SC: ISO/TC 210 Number of Pages: -
Revised by: ISO 13485:2003
