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T/CSBME 032-2021 in English

T/CSBME 032-2021 in English

VALID

Technical requirements for raw materials of medical 4-arm Poly(ethylene glycol) succinimide glutarate

  • Issued on:2021-01-16
  • Implemented on:-
  • File Format:PDF
  • Delivery:Via email within 5 business days
Price(USD): $310.00
$301.00
Standard No: T/CSBME 032-2021
Document status: VALID
Title in English: Technical requirements for raw materials of medical 4-arm Poly(ethylene glycol) succinimide glutarate
Title in Chinese: 医用四臂聚乙二醇琥珀酰亚胺戊二酸酯原材料技术要求
Language: English
File Format: Electronic (PDF)
Delivery: Via email within 5 business days
Issued on: 2021-01-16
ICS Classification: 11.120.20-Medical materials
Chinese Classification: C48-Medical sanitary products
Professional Classification: T/-Social Organization Standard
Related Keywords: medical four-arm polyethylene glycol succinimide glutarate
raw materials
technical requirements
succinimide glutarate scopethis document
quality requirements
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Stabilizing effect of succinylation
Ethylene glycol technical requirements
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t/csbme 078
Imidodiacetic acid

本文件规定了医用四臂聚乙二醇琥珀酰亚胺戊二酸酯原材料的质量要求、试验方法、检验规则、包装、运输和贮存要求。本文件适用于以季戊四醇、环氧乙烷为起始原料,经聚合、修饰、纯化而制成四臂聚乙二醇琥珀酰亚胺戊二酸酯,应用于制造组织封合渗漏、填充、防粘连等医疗器械产品。


Scope

This document specifies the quality requirements, experimental methods, inspection rules, packaging, transportation and storage requirements for the raw materials of medical four-arm polyethylene glycol succinimide glutarate.

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