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ISO 10993-12:2007

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

Publication date:   Oct 31, 2007

95.99 Withdrawal of Standard   Jun 29, 2012

General information

95.99 Withdrawal of Standard   Jun 29, 2012

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100.20   Biological evaluation of medical devices

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Scope

ISO 10993-12:2007 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 the ISO 10993 series. Specifically ISO 10993-12:2007 addresses:
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 10993-12:2007 is not applicable to materials or devices containing live cells.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 10993-12:2002

NOW

WITHDRAWN
ISO 10993-12:2007
95.99 Withdrawal of Standard
Jun 29, 2012

REVISED BY

WITHDRAWN
ISO 10993-12:2012