ISO 13485:1996

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

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

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Historical

ISO 13485:1996

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

Are the documents at the ANSI Webstore in electronic Adobe Acrobat PDF format only?

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