GB 9706.202-2021 Active
GB 9706.202-2021 Medical electrical equipment—Part 2-2:Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Abstract
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.
This document applies to the basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories.
High-frequency surgical equipment with a rated output power not exceeding 50 W (such as miniature coagulators, or equipment used in dentistry or ophthalmology) is excluded from certain requirements of this document, and these exclusions will be indicated in the relevant requirements.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB 9706.202-2021 |
| CCS | Medical ultrasound, laser, and high-frequency instruments and equipment |
| ICS | Surgical instruments and materials |
| Implement Date | 2023-05-01 |