YY 0607-2007 Medical electrical equipment—Part 2:—Particular requirements for the safety of nerve and muscle stimulators
YY 0607-2007 Medical electrical equipment—Part 2:—Particular requirements for the safety of nerve and muscle stimulators
Basic Information
Scope
Except for the following chapters, this chapter of GB 9706.1—1995 "Medical Electrical Equipment—Part 1: General Safety Requirements" applies. Addition: This dedicated standard specifies the safety requirements for nerve and muscle stimulators (hereinafter referred to as stimulators) used in physical medicine practice, as defined in 2.1.101. However, the following devices are not included: — Instruments intended for implantation or connected to implanted electrodes; — Devices used for brain stimulation (such as electroconvulsive therapy devices); — Devices used for neurological research; — Pacemakers (partly applicable to IEC 60601-2-31); — Body-worn devices; — Stimulators used during surgical procedures; — Devices used for evoked response diagnosis (applicable to IEC 60601-2-40); — Myoelectricity equipment (applicable to IEC 60601-2-40); — Cardiac defibrillation devices; — Percutaneous nerve and muscle stimulators used solely for pain relief.