GB/T 42753-2023 Active National standards

GB/T 42753-2023 General principles for performance evaluation of quantitative real-time polymerase chain reaction analyzer

GB/T 42753-2023 General principles for performance evaluation of quantitative real-time polymerase chain reaction analyzer

Publish Date: 2023-05-23 Implement Date: 2023-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 42753-2023

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Electrochemical, thermochemical, and optical analytical instruments

ICS Name: Chemical laboratories, laboratory equipment

Publish Date: 2023-05-23

Implement Date: 2023-12-01

Pages: 22 pages

Scope

This document specifies the requirements, evaluation methods, and evaluation reports for real-time fluorescence quantitative PCR instruments. This document is applicable to the performance evaluation of real-time fluorescence quantitative PCR instruments, including fluorescence quantitative PCR instruments for medical clinical diagnosis and general analysis. Other devices based on the principle of polymerase chain reaction for quantitative or qualitative analysis of target nucleic acid fragments can refer to this document for implementation.

Development Information

Word Count: 35 Thousand words Pages: 22 pages

Referenced Standards

GB/T 34065-2017 Safety requirements for analyzers GB/T 11606-2007 Methods of environmental test for analytical instruments 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 GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment GB/T 34797-2017 Quality technical requirements of primers and probes GB/T 35542-2017 Taq DNA polymerase 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 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements 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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