GB/T 33806-2017 Active National standards

GB/T 33806-2017 Technical requirement of area fluorescent imaging microarray scanner

GB/T 33806-2017 Technical requirement of area fluorescent imaging microarray scanner

Publish Date: 2017-05-31 Implement Date: 2017-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 33806-2017

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Diagnostic equipment

Publish Date: 2017-05-31

Implement Date: 2017-12-01

Pages: 10 pages

Scope

This standard specifies the terms and definitions, basic parameters, requirements, test methods, inspection rules, marking, labels, and user manuals, packaging, transportation, and storage for planar-array fluorescence imaging microarray chip scanners (hereinafter referred to as scanners).
This standard applies to in vitro diagnostic medical devices that use planar substrates as carriers and are based on CCD (Charge Coupled Device) and CMOS (Complementary Metal Oxide Semiconductor) detectors to perform single and multiple imaging of planar-array fluorescence imaging microarray chips.

Development Information

Word Count: 18 Thousand words Pages: 10 pages

Referenced Standards

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods 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 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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