YY 0945.2-2015
Medical electrical equipment.Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source (English Version)
- Standard No.
- YY 0945.2-2015
- Language
- Chinese, Available in English version
- Release Date
- 2015
- Published By
- Professional Standard - Medicine
- Status
- Latest
- YY 0945.2-2015
- Replace By
- YY 9706.231-2023
- Scope
- Supplement: This special standard specifies special safety requirements applicable to external cardiac pacemakers with internal power sources as defined in 2.1.101. This standard applies to patient cables as defined in 2.1.104. This standard does not apply to equipment connected directly or indirectly to the power supply network. This standard does not apply to pacing electrodes or other equipment used for ECG simulation: 1) becoming an internal part of a device with other functions; or 2) allowing stimulation to pass through the chest or esophagus from the outside; or 3) on high-speed pacing Provide anti-tachycardia energy; or 4) Provide pacing system analysis capabilities. Each chamber of a dual-chamber device shall comply with the requirements of this standard.
YY 0945.2-2015 history
- 2015 YY 0945.2-2015 Medical electrical equipment.Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source
YY 0945.2-2015 Medical electrical equipment.Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source was changed to 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.
