This standard specifies the terms and definitions, classification and nomenclature, requirements, test methods, signs and instructions for use, packaging, transportation and storage of polymerase chain reaction analyzers (hereinafter referred to as PCR machines). This standard applies to PCR machines that amplify, detect, and analyze nucleic acid samples.
YY/T 1173-2010 Referenced Document
GB 4793.1 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 1:General requirements
GB/T 14710 Enviromental requirement and test methods for medical electrical equipment
GB/T 191 Packaging.Pictorial marking for handling of goods
YY 0648-2008 Safety requirments for electrical equipment for measurement,control and laboratory use.Part 2-101:Particular requirments for in vitro diagnostic(IVD)medical equipment
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