T/CSBME 021-2020 Active Group standards

T/CSBME 021-2020 The lubrication performance evaluation method for urethral catheter hydrophilic coating

Publish Date: 2020-12-13 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/CSBME 021-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Generally, it refers to microsurgical instruments

ICS Name: Blood transfusion, infusion, and injection equipment

Publish Date: 2020-12-13

Implement Date: 2021-03-01

Scope

Scope: This standard specifies the testing and evaluation of the lubricity and lubrication stability of urinary catheters with hydrophilic coatings. This standard applies to the evaluation of the lubrication performance of urinary catheter hydrophilic coatings. The lubrication performance of other non-vascular catheters/guidewires or certain vascular catheter guidewires can also refer to this standard for evaluation, but appropriate test conditions and evaluation methods should be selected according to the product characteristics and specific application requirements. Note: This standard tests the friction force/friction coefficient of urinary catheter hydrophilic coatings under suitable test conditions. The average value of the friction force/friction coefficient during multiple cycles of friction is used to compare the lubricity of the hydrophilic coating. At the same time, the changes in the friction force/friction coefficient during multiple cycles of friction are observed and analyzed to compare the stability of the lubrication performance of the hydrophilic coating, and can also provide some reference for the evaluation of the coating's firmness. Main technical content: This standard mainly specifies the testing and evaluation of the lubricity and lubrication stability of urinary catheters with hydrophilic coatings from the aspects of test models, test methods, analysis of test results, and reporting.