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ISO 13485:1996

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

Standard Details

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Status : WITHDRAWN
Standard Type: Main
Document No: ISO 13485:1996
Document Year: 1996
Pages: 10
Edition: 1
  • Section Volume:
  • ISO/TC 210. Quality management and corresponding general aspects for medical devices
  • ICS:
  • 03.100.70 Management systems *Standards included in this sub-group shall also be included in other groups and/or sub-groups according to their subject *Including environmental management systems (EMS), road traffic management systems, energy management systems, hea
  • 11.040.01 Medical equipment in general

Life Cycle

WITHDRAWN

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WITHDRAWN
ISO 13485:1996
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