直升机机载医疗救护系统适航审定技术分析与研究

Analysis and Research on Airworthiness Certification Technology for Helicopter Aeromedical Rescue System

摘要:

机载医疗救护系统是直升机实行医学救援的必要设备，适航性是机载医疗救护系统的最低安全性要求，加改装医疗救护系统会直接影响飞机的安全运行，需要经过严格的适航审定程序。我国医疗设备行业普遍缺乏全流程适航经验，严重阻碍国产机载医疗设备行业发展。从机载医疗救护系统的基本构成和装机要求出发，介绍机载医疗救护系统常用构型、功能需求和适航试验要求，依据《运输类旋翼航空器适航规定》的相应条款要求，分析机载医疗救护系统可接受的符合性方法及验证试验中可接受的判据。机载医疗救护设备除了需要通过医疗设备标准性能试验之外，还需要按照适航要求开展环境试验，着重需要对除颤设备充放电过程的电磁兼容性进行检测。适航审定时，民航局应邀请医疗设备专家，给出专业性建议和判断，以评判是否符合适航要求。

Abstract:

The aeromedical rescue system is a necessary equipment for helicopter medical rescue, and retrofitting the medical rescue system will directly affect the safe operation of the aircraft, requiring strict airworthiness certification procedures. Airworthiness is the minimum safety requirement for the development of aeromedical rescue systems. The medical equipment industry generally lacks full process airworthiness experience, which seriously hinders the development of domestic aeromedical equipment industry. Starting from the basic composition and installation requirements of aeromedical rescue systems, this article introduces the classic configuration, functional requirements, and airworthiness test requirements of aeromedical rescue systems. Based on the corresponding provisions of Part 29 R2 "Airworthiness Regulations for Transport Rotorcraft" of the CCAR, the acceptable compliance methods of aeromedical rescue systems and the acceptable criteria in verification tests are analyzed. In addition to passing the medical equipment standard performance test, aeromedical rescue equipment also needs to undergo environmental testing in accordance with requirements, with a focus on testing the electromagnetic compatibility during the charging and discharging process of defibrillation equipment. During airworthiness certification, the Civil Aviation Administration of China should invite medical equipment experts to provide professional advice and judgments to assess whether it meets airworthiness requirements.