YY/T 1262-2015
Active
Industry standards-Medicine
YY/T 1262-2015 Neuron specific enolase quantitative labelling immunoassay kit
YY/T 1262-2015 Neuron specific enolase quantitative labelling immunoassay kit
Basic Information
Standard Code:
YY/T 1262-2015
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2015-03-02
Implement Date:
2016-01-01
Pages:
8 pages
Scope
This standard specifies the quality requirements, testing methods, marking, labeling, and user manuals for neuron-specific enolase quantitative immunoassay kits, as well as their packaging, transportation, and storage.
This standard applies to immunoassay kits used for quantitative determination of neuron-specific enolase (hereinafter referred to as NSE). These kits include those that use enzyme-labeled, chemiluminescence-labeled, or time-resolved fluorescence-labeled methods for capturing antibodies, and those that use microplates, tubes, magnetic particles, microbeads, and plastic beads as carriers for antibody coating and NSE quantitative determination.
Development Information
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
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
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
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