YY 9706.241-2020 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.
Replacement:
This part applies to surgical shadowless lamps and diagnostic lighting lamps (hereinafter referred to as ME devices) for basic safety and basic performance.
This part does not apply to
——headlamps;
——endoscopes and laparoscopes and their light sources covered by GB 9706.19;
——dental lighting lamps covered by YY/T 1120;
——general lighting lamps covered by GB 7000.201 and GB 7000.204;
——therapeutic lamps;
——special-purpose dedicated light sources, such as ultraviolet light for dermatological diagnosis, ophthalmic slit lamps, surgical microscope lamps, and lamps for surgical navigation systems;
——lamps connected to surgical instruments;
——emergency lighting lamps covered by GB 7000.2.
Note: See Article 4.2 of the General Standard.