Standard

ISO 13485:1996

Withdrawn

Note: Latest version: ISO 13485:2016

Existing or new amendments and versions must be purchased 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.

Products specifications

  • Standard from ISO
  • Published:
  • Withdrawn:
  • Period for objection until:
  • Edition: 1
  • Document type: IS
  • Pages
  • Publisher: ISO
  • Distributor: ISO
  • ICS: 03.100.70
  • ICS: 11.040.01
  • International TC: ISO/TC 210

Product Relations

Product life cycle