Shopping cart 0
Standard

ISO 10993-1:2003

Withdrawn

Note: This standard has a draft: ISO/FDIS 10993-1

Preview

Corrigendums and amendments are bought separately.

Language
Services

Abstract

ISO 10993-1:2003 describes the general principles governing the biological evaluation of medical devices;the categorization of devices based on the nature and duration of their contact with the body;the selection of appropriate tests. It does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests.

Document information

  • Standard from ISO
  • Published:
  • Withdrawn:
  • Edition: 3
  • Version: 1
  • Document type: IS
  • Pages
  • ICS 11.100.20
  • ISO TC ISO/TC 194

Product Relations

Product life cycle