T/ZSA 96.4-2021 Active Group standards

T/ZSA 96.4-2021 Dialysis Filter Test Method Part 4: Solute Concentration Decay Rate Detection Method

Publish Date: 2021-12-24 Implement Date: 2021-12-25 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/ZSA 96.4-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Metallurgy

ICS Name: Integrated medical equipment

Publish Date: 2021-12-24

Implement Date: 2021-12-25

Scope

Scope: This part specifies the principles of the performance index test for dialyzers, test conditions, test reagents and materials, test instruments and equipment, test samples, test procedures, test data processing, test precision and measurement uncertainty, test quality assurance and control, and test reports, etc. This part is applicable to the test methods and reports of the solute concentration decline rate of dialyzers used on humans. This part is applicable to the evaluation of qualified dialyzer products. This standard is not applicable to plasma separators, blood perfusion devices (blood perfusion devices, plasma adsorbers) and the evaluation of equipment used for continuous renal replacement therapy; Main technical content: This part specifies the principles of the performance index test for dialyzers, test conditions, test reagents and materials, test instruments and equipment, test samples, test procedures, test data processing, test precision and measurement uncertainty, test quality assurance and control, and test reports, etc. This part is applicable to the test methods and reports of the solute concentration decline rate of dialyzers used on humans. This part is applicable to the evaluation of qualified dialyzer products. This standard is not applicable to plasma separators, blood perfusion devices (blood perfusion devices, plasma adsorbers) and the evaluation of equipment used for continuous renal replacement therapy.

Development Information

Same series standard

T/ZSA 96.1-2021 Dialysis device testing method Part 1: Screening factor detection method T/ZSA 96.2-2021 Dialysis Test Method Part 2: Ultrafiltration Coefficient Detection Method T/ZSA 96.3-2021 Dialysis Test Method Part 3: Solute Clearance Detection Method T/ZSA 96.5-2021 Dialysis Filter Test Method Part 5: Method for Detection of Total Solute Clearance T/ZSA 96.6-2021 Dialysis Filter Test Method Part 6: Volume of Blood Chamber Detection Method

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24