T/NBPIA 005.4-2021 Active Group standards

T/NBPIA 005.4-2021 Test Method for Dialyzer Performance Indicators Part 4: Solute Concentration Decay Rate

Publish Date: 2021-01-01 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/NBPIA 005.4-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Laboratory medicine

Publish Date: 2021-01-01

Implement Date: 2021-03-01

Scope

Main technical content: In recent decades, significant progress has been made in the field of hemodialysis, but to date, there is no unified classification standard for dialyzers domestically or abroad. Although the latest ISO 8637-1:2017 and YY 0053-2016 mention some parameters and related test methods for evaluating dialyzer performance, due to the lack of standardized testing conditions and procedures, the parameters provided by different companies are not comparable with each other. Therefore, it is of great significance to determine the parameters to be included in the dialyzer performance evaluation system and to develop corresponding, unified parameter test method standards, so as to reduce the differences in these parameter test requirements among dialyzer companies and facilitate the clinical evaluation and classification of dialyzer performance. This standard combines the characteristics of the dialyzer industry and draws on the dialyzer standard models of related industries to determine the main parameters that can be used to evaluate dialyzer performance and scientifically and effectively in vitro and/or in vivo test methods for dialyzer performance. The dialyzer test methods will provide a scientific basis for dialyzer classification, thereby providing necessary information for dialysis practitioners to make evidence-based choices of clinical use devices and helping to ensure the safety of patients treated with these devices.