T/CSBME 057-2022 Active
T/CSBME 057-2022 Blood adsorption resin for haemoperfusion device
Abstract
This document specifies the technical requirements, test methods, inspection rules, marking, packaging, transportation, storage, and product instructions for adsorption resins used in blood perfusion devices and plasma perfusion devices. This document applies to spherical polymer resins prepared by suspension copolymerization using styrene, divinylbenzene, (methyl) acrylate esters, acrylonitrile, etc. as polymerization monomers, and fatty hydrocarbons, aromatic hydrocarbons, esters, alcohols, etc. as pore-forming agents, under the action of initiators. These resins are cross-linked derivatives and functional group-modified derivatives. The product is mainly used as an adsorbent in blood perfusion devices (or whole blood perfusion devices) and plasma perfusion devices (or plasma adsorbers, plasma adsorption columns). This document is applicable to the quality control of adsorption resins used before filling.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/CSBME 057-2022 |
| CCS | Extracorporeal circulation, artificial organs, and prosthetic devices |
| ICS | Surgical instruments and materials |
| Implement Date | 2022-10-01 |