ISO 13485:1996

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.


General information

  • Current status : Withdrawn
    Publication date : 1996-12
  • Edition : 1
    Number of pages :
  • :
    ISO/TC 210
    Quality management and corresponding general aspects for medical devices
  • 03.100.70
    Management systems
    11.040.01
    Medical equipment in general

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