YY 0989.6-2025 in English
TO BE VALIDImplantable surgical devices Active implantable medical devices Part 6: Particular requirements for active implantable medical devices for the treatment of tachyarrhythmias (including implantable defibrillators)
- Issued on:2025-06-18
- Implemented on:2028-07-01
- File Format:PDF
- Delivery:Via email within 7 business days
$892.00
| Standard No: | YY 0989.6-2025 |
| Document status: | TO BE VALID |
| Title in English: | Implantable surgical devices Active implantable medical devices Part 6: Particular requirements for active implantable medical devices for the treatment of tachyarrhythmias (including implantable defibrillators) |
| Title in Chinese: | 手术植入物 有源植入式医疗器械 第6部分：治疗快速性心律失常的有源植入式医疗器械（包括植入式除颤器）的专用要求 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 7 business days |
| Issued on: | 2025-06-18 |
| Implemented on: | 2028-07-01 |
| ICS Classification: | 11.040.40-Implants for surgery, prosthetics and orthotics |
| Chinese Classification: | C35-Orthopedic devices |
| Professional Classification: | YY-Pharmaceutics |
| Related Keywords: | active implantable medical devices
implantable medical devices implantable surgical devices active implantable defibrillators implantable |
Scope
本文件规定了治疗快速性心律失常的有源植入式医疗器械（包括植入式除颤器）的要求。 本文件适用于植入式心律转复除颤器、植入式心脏再同步治疗/除颤器、具有治疗快速性心律失常功能的有源植入式医疗器械以及有源植入式医疗器械的某些非植入式部件和附件。 本文件不适用于治疗缓慢性心律失常或心脏再同步的有源植入式医疗器械。GB 16174.2—2024规定了此类要求。
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