T/CAMDI 078-2022 Active Group standards

T/CAMDI 078-2022 Determination of residual 1,4-butanediol monomer in medical polyurethane materials by gas chromatography-mass spectrometry (GC-MS)

Publish Date: 2022-08-04 Implement Date: 2022-09-01 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/CAMDI 078-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Blood transfusion, infusion, and injection equipment

Publish Date: 2022-08-04

Implement Date: 2022-09-01

Pages: 7 pages

Scope

Scope: This document describes the method for determining the residual 1,4-butanediol (hereinafter referred to as BDO) monomer in medical polyurethane materials. This document is applicable to the determination of residual BDO monomer in medical polyurethane materials prepared with BDO and other monomers as synthetic raw materials; Main technical content: Medical polyurethanes can be divided into polyester type and polyether type, mainly prepared from polyester/polyether polyols, isocyanates, chain extenders, various additives (antioxidants, lubricants) and so on. Medical polyurethane materials have excellent biocompatibility, adhesiveness, and anti-thrombotic properties, as well as excellent mechanical properties. They can be widely used in artificial hearts, kidneys, artificial skin, bandages, auxiliary materials, drug controlled release, interventional therapy catheters, and family planning products. During the synthesis of medical polyurethanes, monomer 1,4-butanediol is usually introduced as a chain extender. The introduced monomer 1,4-butanediol may exist as a residual in the polyurethane or be generated from the decomposition of the polyurethane raw materials during processing and molding. Various analytical methods can be used to determine the residual 1,4-butanediol (BDO) monomer in medical polyurethane materials, typical methods including gas chromatography (GC) and gas chromatography/mass spectrometry (GC/MS). This document takes GC/MS as the basic method and provides the experimental procedure.