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.


General information

  • Status :  Withdrawn
    Publication date : 1996-12
  • Edition : 1
  • Technical Committee
    :
    ISO/TC 210
    Quality management and corresponding general aspects for medical devices
  • ICS :
    03.100.70
    Management systems
    11.040.01
    Medical equipment in general

Life cycle

A standard is reviewed every 5 years



Revisions / Corrigenda

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