YY 9706.277-2023 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 a clause explicitly states that it only applies to ME devices or ME systems, the title and the text 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.
Replacement:
This document specifies the basic safety and basic performance of robotic-assisted surgical equipment (RASE) and robotic-assisted surgical systems (RASS).
This document applies to robotic-assisted surgical equipment (RASE) and robotic-assisted surgical systems (RASS), hereinafter collectively referred to as ME devices and ME systems.
This document also applies to the interaction conditions and interface conditions of 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 text 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.
If RASE or RASS or their accessories fall within the scope of other dedicated standards, then in addition to this document, the dedicated standard also applies.
For example: GB 9706.202 for high-frequency surgical equipment, GB 9706.218 for endoscopic equipment, IEC 60601-2-22 for laser equipment, GB 9706.237 for ultrasound equipment, YY 9706.246 for surgical tables, etc.