T/CSBME 057-2022 Active Group standards

T/CSBME 057-2022 Blood adsorption resin for haemoperfusion device

Publish Date: 2022-06-18 Implement Date: 2022-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CSBME 057-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical instruments and materials

Publish Date: 2022-06-18

Implement Date: 2022-10-01

Pages: 12 pages

Scope

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.