GB/T 41521-2022General technical requirement of microfluidic chip for multi-index nucleic acid isothermal amplification and detection (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

1 Scope

This document specifies the classification and nomenclature, requirements, test methods, signs, labels and instructions for use, packaging, transportation and storage requirements of multi-index nucleic acid isothermal amplification detection microfluidic chips.

This document applies to multi-index nucleic acid isothermal amplification detection products using microfluidic chips as carriers.

This document does not apply to microfluidic chip products containing other biological function modules, such as microfluidic chips containing nucleic acid extraction, nucleic acid purification and other functions control biochip products.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 191 Graphical signs of packaging, storage and transportation

GB/T 21415-2008 Measurement of calibrator and control substance assignment in biological samples for in vitro diagnostic medical devices traceability

GB/T 29791.1 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1: Terms, definitions and general Require

3 Terms and Definitions

The terms and definitions defined in GB/T 21415-2008, GB/T 29791.1 and the following apply to this document.