AAMI ISO 10993-9 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
Hardcopy , PDF
08-31-2021
English
01-01-2014
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-9:2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of degradation studies
5 Study report
Annex A (normative) - Consideration of the need for
degradation studies
Annex B (informative) - Biodegradation study
considerations
Bibliography
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