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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
24-09-2008
English
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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
Describes test methods for potential evaluation of devices used to produce sensitization or irritation.
| DocumentType |
Standard
|
| Pages |
44
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| Standards | Relationship |
| ISO 10993-10:2010 | Identical |
| CSA ISO 10993-13 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
| CSA ISO 10993-16 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
| CSA ISO 10993-9 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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