T/CAMDI 076-2022 Active Group standards

T/CAMDI 076-2022 The determination of molecular weight and distribution of medical device-grade polysulfone materials using gel permeation chromatography (GPC) method

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 076-2022

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 molecular weight and its distribution of polysulfone materials used in medical devices. This document is applicable to the determination of the molecular weight and its distribution of polysulfone materials used in the manufacture of medical devices; Main technical content: Polysulfone resin is a thermoplastic resin prepared mainly from bisphenol A and 4,4'-dichlorodiphenyl sulfone as starting materials through salt formation and polycondensation reactions. Due to its excellent toughness, high temperature resistance, and good chemical stability, polysulfone resin can be applied in a variety of fields such as aerospace, wires and cables, machinery, food containers, home appliances, and automobiles. In particular, polysulfone resin exhibits good tolerance and anti-creepability to sterilization methods such as steam, ethylene oxide, gamma radiation, and plasma, and can retain excellent mechanical properties after withstanding multiple sterilization cycles. At the same time, polysulfone resin also has excellent biocompatibility, film-forming properties, and highly controllable pore size distribution, making it widely used in high-end medical fields such as hemodialysis membranes, plasma separators, blood concentrators, and core components of medical devices. During the processing and preparation of these high-end medical products, the molecular weight and its distribution of polysulfone resin will affect the interaction force and aggregation behavior between molecular chains, thereby significantly affecting its physical and performance properties. Taking the preparation of hollow fiber membranes for hemodialysis as an example, under the same preparation conditions, the hollow fiber membranes prepared from polysulfone resins with different molecular weights (including number-average molecular weight and weight-average molecular weight) exhibit huge differences in microstructure, porosity, and tensile propertie