Standard

ISO 13485:1996

Withdrawn

Note: This standard has a new edition: ISO 13485:2016

Corrigendums and amendments are bought separately.

Language
Services

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.

Document information

  • Standard from ISO
  • Published:
  • Withdrawn:
  • Expires:
  • Edition: 1
  • Version: 1
  • Document type: IS
  • ICS 03.100.70
  • ICS 11.040.01
  • ISO TC ISO/TC 210

Product Relations

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