มอก. 2395 เล่ม 12-2565

Scope (English)

This standard defines requirements and provides recommendations on procedures for sample preparation and reference material selection for medical device testing in biological testing systems, most of which follow either of the ISO 10993 series of standards. This standard covers the selection of test samples, selection of representative parts from medical devices, preparation of test samples, experimental control, selection and requirements for reference materials, and preparation of sample extracts.