GB 9706.222-2022 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 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 surgical, therapeutic, diagnostic, and plastic laser equipment, which is classified as Class 1C, Class 3B, or Class 4 laser products containing Class 3B or Class 4 enclosed lasers.
In this document, medical electrical equipment or medical electrical systems that transmit laser as an energy source to patients are referred to as "laser devices".
Note 1: Laser products classified as Class 1, Class 1M, Class 2, Class 2M, or Class 3R in these applications are applicable to GB 7247.1-2012 and general standards.
If a chapter or clause only applies to ME devices or ME systems, the title and content of the chapter or clause will clearly state this. If this is not specified, the chapter or clause applies to the relevant ME devices and ME systems.
Except for the physiological effects specified in general standard 7.2.13, the specific requirements within the scope of this document do not include the inherent hazards (sources) of the intended physiological functions of laser devices.
Note 2: See general standard 4.2 Risk management process of ME devices or ME systems.
Note 3: If the laser device is classified as Class 1C and use