YY 9706.262-2021 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 clause explicitly states that it only applies to ME devices or ME systems, the title and the body of the chapter or clause will indicate this. If this is not the case, the relevant chapter or clause 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.
Addition:
This part applies to high-intensity ultrasound therapy equipment (hereinafter referred to as ME devices) for the basic safety and basic performance.
This part adds or replaces specific provisions for high-intensity ultrasound therapy equipment in GB 9706.1.
If a chapter or clause specifically applies only to ME devices or only to ME systems, this is indicated in the title or content of the chapter or clause. If this is not the case, the chapter or clause applies to both ME devices and ME systems.
The inherent hazards in the intended physiological functions of ME devices and ME systems within the scope of this part are not included in the special requirements of this part, except for the general standards 7.2.13 and 8.4.1.
Note 1: See also the general standard 4.2.
Note 2: In the HITU sound field, due to the influence of non-linear propagation, the sound waveform is expected to be severely distorted. Therefore, ultrasound measurement should be carried out under quasi-linear conditions, and then extrapolated according to the steps given in IEC/TS 62556, see IEC/TS 61949.
Note 3: The asterisk (*) as the first character of the title or the beginning of a paragraph or table heading indica