15/30290736 DC : 0
Superseded
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BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
Hardcopy , PDF
English
31-05-2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Types of devices in contact with blood
(as categorized in ISO 10993-1:2009)
6 Characterization of blood interactions
Annex A (informative) - Preclinical evaluation of
cardiovascular devices and prostheses
Annex B (informative) - Recommended laboratory
tests - principles, scientific basis and Interpretation
Annex C (informative) - Thrombosis - Methods for
in vivo testing
Annex D (informative) - Haematology/haemolysis
Methods for testing - Evaluation of haemolytic
properties of medical devices and medical device
materials
Annex E (informative) - Complement - Methods for testing
Annex F (informative) - Less common laboratory tests
Annex G (informative) - Tests which are not recommended
Bibliography
BS EN ISO 10993-4.
| Committee |
CH/194
|
| DocumentType |
Draft
|
| Pages |
83
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
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