GB/T 21709.14-2009
Active
YY/T 0616.7-2020
Active
Industry standards-Medicine
YY/T 0616.7-2020 Medical gloves for single use—Part 7:Test method for the immunological measurement of antigenic protein
YY/T 0616.7-2020 Medical gloves for single use—Part 7:Test method for the immunological measurement of antigenic protein
Basic Information
Standard Code:
YY/T 0616.7-2020
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Pharmaceutical Science
Publish Date:
2020-09-27
Implement Date:
2021-09-01
Pages:
12 pages
Scope
This part of YY/T 0616 specifies the testing principles, instruments, reagents, and consumables, as well as the measurement methods and test reports for immunological determination of the antigenic protein content in single-use medical natural latex gloves.
This part is applicable to the quantitative determination of the antigenic protein content in single-use medical natural latex gloves.
Development Information
Referenced Standards
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices
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