YY/T 1304.1-2015 Active Industry standards-Medicine

YY/T 1304.1-2015 Detection system of time-resolved fluoroimmunoassay—Part 1:Semi-auto time-resolved fluoroimmunoassay analyser

YY/T 1304.1-2015 Detection system of time-resolved fluoroimmunoassay—Part 1:Semi-auto time-resolved fluoroimmunoassay analyser

Publish Date: 2015-03-02 Implement Date: 2016-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1304.1-2015

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: 7 pages

Scope

This part of YY/T 1304 specifies the terms and definitions, requirements, and test methods for semi-automatic time-resolved fluorescence immunoanalyzers (hereinafter referred to as analyzers), as well as their marking, labeling, and user manuals, packaging, transportation, and storage.
This part applies to single-label time-resolved fluorescence immunoanalysis.
This part does not apply to dual-label and multi-label time-resolved fluorescence immunoanalysis.

Development Information

Word Count: 12 Thousand words Pages: 7 pages

Same series standard

YY/T 1304.2-2015 Detection system of time-resolved fluoroimmunoassay—Part 2:Quantitative reagent(kit) for time-resolved fluoroimmunoassay

Referenced Standards

GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment YY 0648-2008 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD) medical equipment GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements YY/T 0648-2025 Safety requirements for electrical equipment for measurement,control,and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD)medical equipment

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