AAMI ISO 10993-16:2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
Hardcopy , PDF
04-06-2024
English
01-01-2014
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-16:2010
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of toxicokinetic studies
5 Guidance on test methods
Annex A (normative) - Circumstances in which toxicokinetic
studies shall be considered
Bibliography
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