YY 9706.210-2021 Active
YY 9706.210-2021 Medical electrical equipment—Part 2-10:Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Abstract
This part of GB/T 1 specifies the structure of standards, drafting expression rules, and formatting, and provides guidelines on expression styles.
This part is applicable to the preparation of national standards, industry standards, and local standards, as well as national standardized guidance technical documents. The preparation of other standards can be used for reference.
Replacement:
This part specifies the safety requirements for nerve and muscle stimulators (hereinafter referred to as ME devices) used in physical medicine practice. It includes transcutaneous electrical nerve stimulators and electrical muscle stimulators.
Note 1: Muscle stimulators can also be considered as neuromuscular stimulators.
Note 2: Some more important requirements are annotated in the "Special Guidelines and Principle Explanations" section, see Appendix AA.
This part does not apply to the following ME devices:
—— ME devices used for implantation or connected to implanted electrodes;
—— ME devices used for brain stimulation (such as ME devices for electroconvulsive therapy);
—— ME devices used for neurological research;
—— External pacemakers (see YY 0945.2);
—— ME devices used for evoked response diagnosis (see YY 9706.240);
—— ME devices used for electromyography (see YY 9706.240);
—— Heart defibrillation ME devices (see GB 9706.8).
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY 9706.210-2021 |
| CCS | Physiotherapy and traditional Chinese medicine instruments and equipment |
| ICS | Treatment equipment |
| Implement Date | 2023-05-01 |