T/NBPIA 005.6-2021 Active Group standards

T/NBPIA 005.6-2021 Test method for performance indicators of dialyzers Part 6: Blood chamber volume

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 005.6-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Computer

ICS Name: Terminology (principles and coordination and cooperation)

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 as of now, 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 the performance of dialyzers, 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 performance evaluation system of dialyzers 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 of the performance of dialyzers and their classification. 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 the performance of dialyzers and the scientific and effective in vitro and/or in vivo test methods for dialyzer performance. The dialyzer test methods will provide a scientific basis for the classification of dialyzers, thereby providing necessary information for dialysis practitioners to make informed choices about the clinical use of devices and helping to ensure the safety of patients treated with these devices.