AAMI ISO 10993-11 : 2006 : R2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
21-02-2019
01-01-2014
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 10993-11:2006
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Acute systemic toxicity
6 Repeated exposure systemic toxicity (subacute,
subchronic and chronic systemic toxicity)
Annex A (informative) - Routes of administration
Annex B (informative) - Dosage volumes
Annex C (informative) - Common clinical signs and
observations
Annex D (informative) - Suggested haematology, clinical
chemistry and urinalysis measurements
Annex E (informative) - Suggested organ list for
histopathological evaluation
Annex F (informative) - Information on material-mediated
pyrogens
Bibliography
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