GB/T 16886.1-2011 Biological evaluation of medical devices— Part 1: Evaluation and testing within a risk management process (Text of Document is in English)

01/11/2011

35P

$200.00 USD

Contents
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biological evaluation of medical devices
5 Categorization of medical devices
6 Biological evaluation process
7 Interpretation of biological evaluation data and overall biological safety assessment
Annex A (Informative) Biological evaluation tests
Annex B (Informative) Guidance on the risk management process
Annex C (Informative) Suggested procedure for literature review
Bibliography