GB/T 33805-2017 Active National standards

GB/T 33805-2017 Technical requirement of laser confocal biochip scanner

GB/T 33805-2017 Technical requirement of laser confocal biochip 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 33805-2017
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: 9 pages

Scope

This standard specifies the terms and definitions, requirements, test methods, marking, labeling, and user instructions, packaging, transportation, and storage for laser confocal biochip scanners.
This standard applies to in vitro diagnostic medical devices, scanners based on the principle of laser confocal scanning and using a flat substrate as the carrier.

Development Information

Word Count: 15 Thousand words Pages: 9 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 0466-2003 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied 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 0466.2-2015 Medical devices—Symbols to be used with medical device labels, labelling,and information to be supplied—Part 2:Symbol development,selection and validation 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 191-2025 Graphical symbols marking for handling and storage of packages 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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