มอก. 2395 เล่ม 10-2565

Scope (English)

This standard describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce skin sensitization with cover the detail of skin sensitization testing and important factor for analysis of the result. By specifying introduction, scope, reference, definition, principle, pre-test considerations, skin allergy testing, and important factors in interpreting test results.