GB/T 16886.11-1997
Replaced
T/ZSA 96.1-2021
Active
Group standards
T/ZSA 96.1-2021 Dialysis device testing method Part 1: Screening factor detection method
T/ZSA 96.1-2021 Dialysis device testing method Part 1: Screening factor detection method
Price:
$ 20.00
Basic Information
Standard Code:
T/ZSA 96.1-2021
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 dialyzer performance index testing, testing conditions, testing reagents and materials, testing instruments and equipment, testing samples, testing steps, testing data processing, testing precision and measurement uncertainty, testing quality assurance and control, and testing reports, etc. This part applies to the testing method of solute screening coefficients of dialyzers used on humans. This part does not apply to the measurement of solute screening coefficients of blood dialyzers for children, nor to the evaluation of plasma separators, blood concentrators, and devices used in continuous renal replacement therapy; Main technical content: This part specifies the principles of dialyzer performance index testing, testing conditions, testing reagents and materials, testing instruments and equipment, testing samples, testing steps, testing data processing, testing precision and measurement uncertainty, testing quality assurance and control, and testing reports, etc. This part applies to the testing method of solute screening coefficients of dialyzers used on humans. This part does not apply to the measurement of solute screening coefficients of blood dialyzers for children, nor to the evaluation of plasma separators, blood concentrators, and devices used in continuous renal replacement therapy.
Development Information
Same series standard
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 96.4-2021 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