Standard

NS-EN ISO 10993-12:1996

Withdrawn

Note: This standard has a new edition: NS-EN ISO 10993-12:2021

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Abstract

This part of ISO 10993 specifies requirements and gives guidance on procedures to be followed in the preparation of samples of medical devices for testing in biological systems in accordance with one or more other parts of ISO 10993. These include: a) test material selection; b) selection of representative portions from a device; c) test sample preparation; d) the selection of reference materials to demonstrate the suitability of the test system and/or to enable relative comparison of the biological activity of the test sample; and, e) preparation of extracts.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 1
  • Version: 1
  • Document type: NAT
  • ICS 11.020
  • ICS 11.100
  • National Committee SN/K 115

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EU law: 93/42/EEC, 90/385/EEC

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