This standard specifies the technical requirements, test methods, inspection rules, marking, packaging, transportation, storage, etc. of low-frequency electronic pulse therapy instruments. This standard applies to instruments that use low-frequency electronic pulses or direct current to stimulate human acupuncture points directly through filiform needles or skin electrodes for treatment and health care.
YY 0016-1993 history
2021YY 9706.210-2021 Medical electrical equipment Part 2-10: Specific requirements for basic safety and essential performance of nerve and muscle stimulators
2008YY 0607-2007 Medical electrical equipment—Part 2: Particular requirements for the safety of nerve and muscle stimulators
1993YY 0016-1993 Low Frequency Electronic Pulse Therapy Apparatus
YY 0016-1993 Low Frequency Electronic Pulse Therapy Apparatus was changed to YY 0607-2007 Medical electrical equipment—Part 2: Particular requirements for the safety of nerve and muscle stimulators.