YY/T 1243-2014 Active Industry standards-Medicine

YY/T 1243-2014 Creatine kinase test reagent(kit)

YY/T 1243-2014 Creatine kinase test reagent(kit)

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 1243-2014

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 terms and definitions, requirements, test methods, labels, user manuals, packaging, transportation, and storage for creatine kinase assay reagents (kits).
This standard applies to creatine kinase assay reagents (kits) used for quantitative detection of creatine kinase activity in serum or plasma using continuous monitoring methods, including manual reagents and reagents used on semi-automatic and fully automatic biochemical analyzers.
This standard does not apply to dry creatine kinase assay reagents (kits).

Development Information

Word Count: 20 Thousand words Pages: 11 pages

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 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 GB 3100-1993 SI units and recommendations for the use of their multiples and of certain other units 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 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis

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