Maki B, Laszlo C A
J Clin Eng. 1980 Apr-Jun;5(2):133-8. doi: 10.1097/00004669-198004000-00008.
A wide variety of mechanical hazards are associated with clinical instrumentation containing mechanical components. Therefore, safety considerations for clinical equipment must be extended to include mechanical safety standards, maintenance programs, and operating procedures. Mechanical risk classes have been developed from the study of mechanical-mode failures of medical devices. To facilitate the development of priorities for clinical engineering involvement in mechanical safety programs, most mechanical devices which are commonly used in clinical practice have been assigned an appropriate risk classification. General recommendations for the development of such programs are also presented.
包含机械部件的临床仪器存在各种各样的机械危害。因此，临床设备的安全考量必须扩展至包括机械安全标准、维护计划及操作程序。机械风险等级是通过对医疗设备机械模式故障的研究而制定的。为便于确定临床工程在机械安全计划中的工作重点，临床实践中常用的大多数机械设备都已被赋予了适当的风险分类。本文还给出了制定此类计划的一般性建议。
