This standard specifies the terms and definitions, classification, requirements and test methods of myoelectric biofeedback equipment.
This standard is applicable to the myoelectric biofeedback equipment specified in 3.1.
This standard is not applicable to the equipment using catwhisker to record myoelectric signals and the myoelectric evoked potential meter.
2 Normative References
The following documents for the application of this document are essential. For dated reference, only the edition cited applies. For undated reference, the latest edition of the referenced document (including any amendments) applies.
GB 9706.1-2007 Medical Electrical Equipment - Part 1: General Requirements for Safety
GB 9706.15-2008 Medical Electrical Equipment - Part 1: General Requirements for Safety - 1. Collateral standard: Safety Requirements for Medical Electrical Systems
GB/T 14710-2009 Environmental Requirement and Test Methods for Medical Electrical Equipment
GB/T 16886.1-2011 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
YY 0505-2012 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standards: Electromagnetic Compatibility - Requirements and Tests
3 Terms and Definitions
For the purposes of this document, terms and definitions given in GB 9706.1-2007 and the following apply.
3.1
myoelectric biofeedback equipment
an equipment to cure disease by using surface electrode to collect the myoelectric signals in the body as the physiologic information, and then visually or aurally feeding back the information to the patient to make him/her learn to control his/her own psychological and physiological activities
