BIOASSAY, BIOLOGICAL TESTS, MEDICAL DEVICES, MEDICAL EQUIPMENT, REFERENCEMATERIALS, SPECIMEN PREPARATION, TEST SPECIMENS, TESTS
被代替标准
2002-01-01
适用范围
This National Standard of Canada is equivalent to International Standard ISO 10993-12:1996. 1 Scope 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 selectrion; 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.