CSA ISO 10993-10 : 0
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SENSITIZATION
Hardcopy , PDF
09-24-2008
English
1 Scope
2 Normative references
3 Definitions
4 General principles, step-wise approach
5 Irritation tests
5.1 Factors to be considered in design and
selection of tests
5.2 Skin irritation test
5.3 Ocular irritation test
5.4 Intracutaneous (intradermal) reactivity test
6 Sensitization tests
6.1 Factors to be considered in design and
selection of tests
6.2 Maximization sensitization test
6.3 Closed patch sensitization test
Annexes
A Preparation of materials for testing
B Method for extraction of materials for biological
tests
C Animals and husbandry
D Additional irritation tests
E Background information
F Bibliography
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