T/NBPIA 005.1-2021 Active Group standards

T/NBPIA 005.1-2021 Dialysis device performance test method Part 1: Screening factor

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 005.1-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: \nTest methods for the physical and chemical properties of metals

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 so far, there is no unified classification standard for dialyzers at home and 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 detection conditions and steps, 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 develop corresponding, unified parameter test method standards, in order 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 scientific and effective in vitro and/or in vivo test methods for dialyzer performance. The test methods for dialyzer performance indicators 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.