YY/T 1232-2014 Active Industry standards-Medicine

YY/T 1232-2014 γ-Glutamyl transpeptadase test reagent kit(Method of GPNA)

YY/T 1232-2014 γ-Glutamyl transpeptadase test reagent kit(Method of GPNA)

Publish Date: 2014-06-17 Implement Date: 2015-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1232-2014

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2014-06-17

Implement Date: 2015-07-01

Pages: 11 pages

Scope

This standard specifies the technical requirements, test methods, labels, user manuals, packaging, transportation, and storage for γ-glutamyltransferase assay reagents (kits) (GPNA substrate method).
This standard applies to γ-glutamyltransferase assay reagents (kits) that use the L-γ-glutamyl-3-carboxylic-phenylamide substrate method to quantitatively detect γ-glutamyltransferase activity in serum or plasma, including manual reagents and reagents used on semi-automatic and fully automatic biochemical analyzers.
This standard does not apply to dry γ-glutamyltransferase assay reagents (kits).

Development Information

Word Count: 20 Thousand words Pages: 11 pages

Referenced Standards

GB 3100-1993 SI units and recommendations for the use of their multiples and of certain other units 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 0316-2003 Medical devices—Application of risk management to medical devices YY/T 0316-2008 Medical devices—Application of risk management to medical devices YY/T 0316-2016 Medical devices—Application of risk management to medical devices 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 YY/T 0638-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis GB/T 21415-2025 In vitro diagnostic medical devices—Requirements for establishing metrological traceability of values assigned to calibrators,trueness control materials and human samples

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