มอก. 2395 เล่ม 6-2563

Scope (English)

This standard specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to materials that are — solid and non-absorbable, — non-solid, such as porous materials, liquids, gels, pastes, and particulates, and — degradable and/or absorbable, which may be solid or non-solid.