GB 9706.1-2020 Active
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
Abstract
This part of GB 9706 stipulates 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 body 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.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB 9706.1-2020 |
| CCS | Medical devices |
| ICS | Medical equipment |
| Implement Date | 2023-05-01 |