ANSI/AAMI/ISO 10993-6:2016
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
Hardcopy , PDF
English
01-10-2017
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
ISO 10993-6:2016
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Common provisions for implantation
test methods
5 Test methods, general aspects
6 Test report
Annex A (normative) - Test methods for
implantation in subcutaneous
tissue
Annex B (normative) - Test method for
implantation in muscle
Annex C (normative) - Test method for
implantation in bone
Annex D (normative) - Test method for
implantation in brain tissue
Annex E (informative) - Examples of
evaluation of local biological
effects after implantation
Bibliography
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