GB/T 41521-2022 General technical requirement of microfluidic chip for multi-index nucleic acid isothermal amplification and detection (English Version)
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
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GB/T 41521-2022
Scope
This document specifies the classification and naming, requirements, test methods, signs, labels and instructions, requirements for packaging, transportation and storage of multi-index nucleic acid constant temperature amplification detection microfluidic chips. This document applies to multi-index nucleic acid constant temperature amplification detection products using microfluidic chips as carriers. This document does not apply to microfluidic chip products containing other biological functional modules, such as microfluidic biochip products including functions such as nucleic acid extraction and nucleic acid purification.
GB/T 41521-2022 Referenced Document
GB/T 191 Packaging.Pictorial marking for handling of goods
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 29791.1 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 1:Terms, definitions and general requirements
GB/T 41521-2022 history
2022GB/T 41521-2022 General technical requirement of microfluidic chip for multi-index nucleic acid isothermal amplification and detection