AAMI ISO 10993-11 : 2006 : R2014

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

Defines requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.