Reference number
ISO 10993-12:2012
© ISO 2024
ISO 10993-12:2012
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Edition 4
2012-07
Withdrawn
Withdrawn (Edition 4, 2012)

Abstract

ISO 10993-12:2012 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, ISO 10993-12:2012 addresses the following:

  • test sample selection;
  • selection of representative portions from a device;
  • test sample preparation;
  • experimental controls;
  • selection of, and requirements for, reference materials;
  • preparation of extracts.

ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.

General information

  • Status
     : Withdrawn
    Publication date
     : 2012-07
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 4
    Number of pages
     : 20
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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