1 Scope
This part of GB/T 16886 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity.
This part of GB/T 16886 includes
a) Pretest considerations,
b) Details of the test procedures, and
c) Key factors for the interpretation of the results.
Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests.
Supplementary tests which are required specifically for devices used intradermally in the ocular, oral, rectal, penile and vaginal areas are given in Annex B.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of GB/T 16886. For dated references, subsequent amendments (excluding corrections) to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of GB/T 16886 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
Contents
Foreword i
Introduction iii
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
Annex B (Informative) Additional Irritation Tests
Annex C (Informative)
Background Information
Bibliography
