This standard specifies the basic parameters, technical requirements, test methods, inspection rules and marking, packaging, transportation and storage requirements of the instrument. This instrument is mainly used for blood flow chart examination of the brain, limbs, internal organs, etc. for clinical diagnosis or physiological research. This standard applies to direct impedance blood flow meters (hereinafter referred to as instruments).
YY/T 1078-2008 Referenced Document
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 191-2008 Packaging.Pictorial marking for handling of goods
YY 0505-2005 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests