YY/T 1194-2011 Active Industry standards-Medicine

YY/T 1194-2011 α-Amylase test reagent (kit)(continuous-monitoring procedure)

YY/T 1194-2011 α-Amylase test reagent (kit)(continuous-monitoring procedure)

Publish Date: 2011-12-31 Implement Date: 2013-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1194-2011

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2011-12-31

Implement Date: 2013-06-01

Pages: 11 pages

Scope

This standard specifies the terms and definitions, classification and naming, technical requirements, test methods, labels, user manuals, packaging, transportation, and storage requirements for α-amylase assay reagents (kits).
This standard applies to α-amylase assay reagents (kits) used for quantitative detection of α-amylase activity in body fluids such as serum, plasma, and urine using continuous monitoring methods, including manual reagents and reagents used on semi-automatic and fully automatic biochemical analyzers.

Development Information

Word Count: 18 Thousand words Pages: 11 pages

Referenced Standards

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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