GB 5197.1-1996
Abolished
YY/T 1448-2016
Active
Industry standards-Medicine
YY/T 1448-2016 Lipoprotein(a) test reagent
YY/T 1448-2016 Lipoprotein(a) test reagent
Basic Information
Standard Code:
YY/T 1448-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Medical and health technology
Publish Date:
2016-01-26
Implement Date:
2017-01-01
Pages:
9 pages
Scope
This standard specifies the requirements for lipoprotein (a) assay kits, including testing methods, marking, labeling and user manuals, packaging, transportation, and storage.
This standard applies to kits used for quantitative detection of lipoprotein (a) in human serum or plasma by immunoturbidimetry (transmission method), including manual reagents and reagents used on semi-automatic and fully automatic biochemical analyzers.
Development Information
Referenced Standards
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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GB/T 37237-2018
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