GB/T 16886.10-2005

GB/T 16886.10-2005 医疗器械生物学评价 第10部分:刺激与迟发型超敏反应试验 （英文版）

Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity

2005-03-23

2005-12-01

84

20.00元

是

1,200.00元

Word/PDF

Contents
Foreword
Introduction
1 Scope
2 Normative References
3 Terms and definitions
4 General principles — Step-wise approach
5 Pretest considerations
6 Irritation tests
7 Delayed hypersensitivity tests
8 Key factors in interpretation of test results
Annex A (Normative) Preparation of materials for irritation/sensitization testing
A.1 General
A.2 Materials for direct-contact exposure
A.3 Extracts of test materials
A.4 Solvents
A.5 Sterile test materials
Annex B (Informative) Additional irritation tests
B.1 General
B.2 Intracutaneous (intradermal) reactivity test
B.3 Ocular irritation test
B.4 oral mucosa irritation test
B.5 Penile irritation test
B.6 Rectal irritation test
B.7 Vaginal irritation test
Annex C (Informative) Background information
C.1 Background information on irritation tests
C.2 Background information on sensitization tests for delayed hypersensitivity
Bibliography

GB/T 16886.10 英文版 English Version