GB/T 16886.10-2005 Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity (Text of Document is in English)

01/12/2005

84P

$240.00 USD

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