GB/T 16886.1-2011

GB/T 16886.1-2011 医疗器械生物学评价 第1部分：风险管理过程中的评价与试验 (英文版)

Biological evaluation of medical devices— Part 1: Evaluation and testing within a risk management process

2011-06-16

2011-11-01

35

10.00元

是

1,150.00元

PDF/Word

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

GB/T 16886.1 英文版 English Version