This document specifies requirements and test methods for polyurethane foam dressings applicable to dressings in which the liquid absorbent layer supplied aseptically is polyurethane foam. It does not apply to polyurethane foam dressings containing bacteriostatic agents, active ingredients or releasing active substances/energy, materials of human/animal origin, tissue engineering materials, degradable materials, etc., and polyurethane foam dressings for negative pressure drainage. Required referenced documents include standards on medical infusion, biological evaluation of medical apparatus, final sterilized medical apparatus Encasement, medical apparatus logo and symbols providing information, etc. There are no terms and definitions that need to be defined in this document. The common structure of polyurethane foam dressings is shown in the figure.
| Status | Active |
|---|---|
| CCS | (C48) 医用卫生用品 | ICS | (11.120.20) 医用材料 |
| Release Date | 2022-10-17 00:00:00 | Implementation Date | 2023-10-01 00:00:00 |