YY 9706.231-2023
Medical electrical equipment Part 2-31: Specific requirements for basic safety and essential performance of external cardiac pacemakers with internal power supply (English Version)
- Standard No.
- YY 9706.231-2023
- Language
- Chinese, Available in English version
- Release Date
- 2023
- Published By
- 国家药监局
- Latest
- YY 9706.231-2023
- Replace
- YY 0945.2-2015
- Scope
- This document specifies the basic safety and essential performance of external cardiac pacemakers powered by an internal power supply. This document applies to cables extending the distance between non-implantable pulse generators and pacing electrode leads, but does not apply to cables enclosed with one or more insulated conductors intended for use between an external cardiac pacemaker and the patient's heart. A hose that transmits electrical energy between. This document does not apply to the implanted parts of active implantable medical devices covered by GB 16174.1, external cardiac pacemakers that can be directly or indirectly connected to the power supply network, medical electrical equipment for transthoracic and esophageal pacing, and anti-cardiac devices Excessive medical electrical equipment.
YY 9706.231-2023 history
- 2023 YY 9706.231-2023 Medical electrical equipment Part 2-31: Specific requirements for basic safety and essential performance of external cardiac pacemakers with internal power supply
YY 9706.231-2023 Medical electrical equipment Part 2-31: Specific requirements for basic safety and essential performance of external cardiac pacemakers with internal power supply has been changed from YY 0945.2-2015 Medical electrical equipment.Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source.
