SN EN ISO 10993-1 : 2010 CORR 2010
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
01-12-2013
Foreword
Introduction
1 Scope
2 Terms and definitions
3 General principles applying to biological evaluation
of medical devices
4 Categorization of medical devices
5 Testing
6 Selection of biological evaluation tests
7 Assurance of test methods
Annex A (informative) Rationale
Annex B (informative) Flow chart to aid in ensuring a
systematic approach to biological evaluation of
medical devices
Bibliography
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