YY/T 1458-2016
Active
Industry standards-Medicine
YY/T 1458-2016 Antibodies to thyroid peroxidase quantitative test reagent(chemiluminescent immunoassay)
YY/T 1458-2016 Antibodies to thyroid peroxidase quantitative test reagent(chemiluminescent immunoassay)
Basic Information
Standard Code:
YY/T 1458-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2016-01-26
Implement Date:
2017-01-01
Pages:
8 pages
Scope
This standard specifies the requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage for quantitative detection reagents (kits) for anti-thyroid peroxidase antibodies (chemiluminescence immunoassay method).
This standard applies to reagents (kits) for quantitatively measuring human anti-thyroid peroxidase antibodies based on the principle of chemiluminescence immunoassay. Anti-TPO reagents (kits) can be divided into enzymatic and non-enzymatic chemiluminescence immunoassay reagents (kits) according to the different principles of chemiluminescence, and into manual operation and instrument-automated operation methods according to the different operating processes.
Development Information
Referenced Standards
GB/T 21415-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
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