This standard specifies the terms and definitions, requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage of hemoglobin dry chemical detection systems. This standard applies to dry chemical hemoglobin detection systems that use the principle of light reflection to detect the hemoglobin concentration in human capillary whole blood and/or venous whole blood. Not suitable for dry chemical hemoglobin testing systems that utilize visual colorimetry or transmission colorimetry.
YY/T 1150-2009 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/T 1150-2009 history
2009YY/T 1150-2009 General technical requirements for hemoglobin dry chemistry testing systems