GB/T 16886.11-1997
Replaced
T/ZSA 96.3-2021
Active
Group standards
T/ZSA 96.3-2021 Dialysis Test Method Part 3: Solute Clearance Detection Method
T/ZSA 96.3-2021 Dialysis Test Method Part 3: Solute Clearance Detection Method
Price:
$ 20.00
Basic Information
Standard Code:
T/ZSA 96.3-2021
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 section specifies three experimental methods for measuring solute clearance, namely the single clearance (in vitro) experimental method, the single clearance (clinical) experimental method, and the fixed-volume recirculation clearance (in vitro) experimental method. Each experimental method specifies the principles of dialyzer performance index testing, experimental conditions, experimental reagents and materials, experimental instruments and equipment, experimental samples, experimental steps, experimental data processing, experimental precision and measurement uncertainty, experimental quality assurance and control, and experimental reports, etc. This section applies to the measurement of solute clearance in dialyzers used on humans. The evaluation objects applicable to this section are qualified dialyzer products. This section does not apply to plasma separators, blood perfusion devices (blood perfusioners, plasma adsorbers), and the evaluation of equipment used for continuous renal replacement therapy. Main technical content: This section specifies three experimental methods for measuring solute clearance, namely the single clearance (in vitro) experimental method, the single clearance (clinical) experimental method, and the fixed-volume recirculation clearance (in vitro) experimental method. Each experimental method specifies the principles of dialyzer performance index testing, experimental conditions, experimental reagents and materials, experimental instruments and equipment, experimental samples, experimental steps, experimental data processing, experimental precision and measurement uncertainty, experimental quality assurance and control, and experimental reports, etc. This section applies to the measurement of solute clearance in dialyzers used on humans. The evaluation objects applicable to this section are qualified dialyzer products. This section does not apply to plasma separators, blood perfusion devices (blood perfusioners, plasma ad
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 96.4-2021 Dialysis Filter Test Method Part 4: Solute Concentration Decay Rate 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 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
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
GB/T 16886.7-2001
Replaced