GB 11243-2000
Replaced
GB/T 41521-2022
Active
National standards
GB/T 41521-2022 General technical requirement of microfluidic chip for multi-index nucleic acid isothermal amplification and detection
GB/T 41521-2022 General technical requirement of microfluidic chip for multi-index nucleic acid isothermal amplification and detection
Basic Information
Standard Code:
GB/T 41521-2022
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Diagnostic equipment
Publish Date:
2022-07-11
Implement Date:
2022-07-11
Pages:
10 pages
Scope
This document specifies the classification and naming, requirements, test methods, marking, labeling, and instructions, as well as the requirements for packaging, transportation, and storage of multi-indicator nucleic acid isothermal amplification detection microfluidic chips. This document applies to multi-indicator nucleic acid isothermal amplification detection products carried by microfluidic chips. This document does not apply to microfluidic chip products containing other biological functional modules, such as microfluidic biochips with functions such as nucleic acid extraction and purification.
Development Information
Referenced Standards
GB/T 21415-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 29791.1-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 1:Terms,definitions and general requirements
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
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