GB 9706.236-2021 Active

This part of GB 9706 specifies the general requirements for the basic safety and basic performance of ME devices and ME systems.
This part applies to medical electrical equipment and medical electrical systems (hereinafter referred to as ME devices and ME systems).
If a chapter or an article explicitly states that it only applies to ME devices or ME systems, the title and the text of the chapter or article will indicate this. If this is not the case, the relevant chapter or article applies to both ME devices and ME systems.
Except for 7.2.13 and 8.4.1, the hazards (sources) caused by the expected physiological effects of ME devices or ME systems within the scope of this part are not specifically required in this part.
This document specifies the basic safety and basic performance of extracorporeal lithotripsy devices.
This document applies to extracorporeal lithotripsy devices defined in 201.3.206, including other medical application devices for treating extracorporeal induced focused pressure pulses, hereinafter referred to as ME devices. The applicability of this document is limited to components directly related to lithotripsy medical treatment. For example (but not limited to), pressure pulse generators, patient support equipment, and related imaging and monitoring equipment. Other devices such as programmable computers used for patient treatment, X-ray and ultrasound equipment are not included in this document.
This document does not apply to:
——ultrasound physical therapy devices intended for physiotherapy use;
——ultrasound equipment (HITU) intended for high-intensity therapy and other treatment devices as described in Appendix AA.