T/NBPIA 005.5-2021 Active Group standards

T/NBPIA 005.5-2021 Dialysis device performance test method - Part 5: Total solute clearance

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 005.5-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: \nBasic standards

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 up to now, there is no unified classification standard for dialysis machines at home and abroad. Although the latest ISO 8637-1:2017 and YY 0053-2016 mention some parameters and related test methods for evaluating the performance of dialysis machines, due to the lack of standardized detection conditions and steps, the parameters provided by different companies are not comparable to each other. Therefore, it is of great significance to determine the parameters to be included in the performance evaluation system of dialysis machines and to develop corresponding, unified parameter test method standards, so as to reduce the differences in these parameter test requirements among dialysis machine companies and facilitate the clinical evaluation of the performance of dialysis machines and their classification. This standard combines the characteristics of the dialysis machine industry and draws on the dialysis machine standard models of related industries to determine the main parameters that can be used to evaluate the performance of dialysis machines and scientific and effective in vitro and/or in vivo test methods for dialysis machine performance. The dialysis machine test methods will provide a scientific basis for the classification of dialysis machines, and in turn, provide necessary information for dialysis practitioners to select clinical use devices based on evidence and help ensure the safety of patients treated with these devices.