GB 9706.237-2020 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 body 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.
Alternatively:
This standard applies to the basic safety and basic performance of ultrasonic diagnostic equipment as defined in 201.3.217 (hereinafter referred to as ME devices).
If a chapter or an article specifically applies only to ME devices or only to ME systems, this will be indicated in the title or 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 standard, except for 7.2.13 and 8.4.1, are not included in the special requirements of this standard.
Note: See also Article 4.2 of this standard.
This standard does not apply to ultrasonic therapy equipment. However, equipment used for imaging or diagnosing human structures by ultrasound is included when used in conjunction with other medical procedures.