T/CSBME 056.2-2022 Active Group standards

T/CSBME 056.2-2022 Blood dialysis membrane material for hollow fiber Part 2: PES (Polyether sulfone)

T/CSBME 056.2-2022 Blood dialysis membrane material for hollow fiber Part 2: PES (Polyether sulfone)

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 056.2-2022

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: 16 pages

Scope

This document specifies the technical requirements, test methods, marking, packaging, transportation, and storage of polyethersulfone, a hollow fiber material used in hemodialysis devices. This document is applicable to the performance evaluation of polyethersulfone, a hollow fiber material used in hemodialysis devices.

Development Information

Word Count: 26 Thousand words Pages: 16 pages

Same series standard

T/CSBME 056.1-2022 Hollow fiber feedstock for hemodialyzers—Part 1:Polysulfone

Referenced Standards

GB/T 2914-2008 Plastics—Homopolymer and copolymer resins of vinyl chloride—Determination of volatile matter (including water) GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 19466.2-2004 Plastics—Differential scanning calorimetry(DSC)—Part 2:Determination of glass transition temperature 《中华人民共和国药典》(2020年版　四部) GB/T 19466.2-2025 Plastics—Differential scanning calorimetry(DSC) method—Part 2:Determination of glass transition temperature and step height

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