T/CSBME 032-2021 Active Group standards

T/CSBME 032-2021 The technical requirements for the raw material of medical four-armed polyethylene glycol succinimidyl succinate are as follows

Publish Date: 2021-01-16 Implement Date: 2021-03-01 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 032-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical hygiene products

ICS Name: Medical materials

Publish Date: 2021-01-16

Implement Date: 2021-03-01

Scope

Scope: This document specifies the quality requirements, experimental methods, inspection rules, packaging, transportation, and storage requirements for medical four-arm polyethylene glycol succinimide succinate raw materials. This document is applicable to four-arm polyethylene glycol succinimide succinate manufactured from starting materials such as pentaerythritol and ethylene oxide through polymerization, modification, and purification, and used in the production of medical device products such as tissue sealing, leakage prevention, filling, and anti-adhesion. Main technical content: This document specifies the quality requirements, experimental methods, inspection rules, packaging, transportation, and storage requirements for medical four-arm polyethylene glycol succinimide succinate raw materials.