GB 11243-2000
Replaced
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
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
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
Related Standards
GB 1588-2001
Replaced
GB 1588-2001 Clinical thermometer
YY 0109-2003
Replaced
YY 0109-2003 Medical ultrasonic nebulizer
YY 0455-2003
Replaced
YY 0455-2003 Medical electrical equipment—Part 2:Particular requirments for the safety of infant radiant warmers
YY/T 1036-2004
Active
YY/T 1036-2004 Impression tonometers
GB/T 19665-2005
Replaced