GB 9706.205-2020 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 intended physiological effects of ME devices or ME systems within the scope of this part are not specifically required in this part.
This part applies to the basic safety and basic performance of ultrasound therapy equipment as defined in 201.3.216. Hereinafter referred to as ME devices.
This part only relates to ultrasound therapy equipment that uses a single planar non-focused circular transducer as the treatment head, which generates a static acoustic beam perpendicular to the end face of the treatment head.
This part also applies to ultrasound therapy equipment that compensates for or alleviates diseases, injuries, or disabilities.
In the case of combination devices (for example, devices that additionally add the function of electrical stimulation or application parts), such devices should also comply with the provisions of the dedicated standards related to the safety requirements of the added functions.
If a chapter or an article specifically applies only to ME devices or only to ME systems, this will be indicated in the title and content of the chapter or article. If this is not indicated, the chapter or article applies to both ME devices and ME systems.
The inherent hazards in the intended physiological functions of ME devices or ME systems within the scope of this part are not included in the special requirements of this