军队医院高频手术设备质量控制检测技术规范探讨

Investigation of the Quality Control Testing Technology Specifications in Clinical Equipment of Army Hospital

目的:为保证高频手术设备在临床应用的使用安全,对高频手术设备的安全参数和工作数据准确性实施有效控制,建立合理完善的检测技术规范。方法:参照《GB 9706.4—1999医用电气设备第二部分:高频手术设备安全专用要求》,结合高频手术设备厂家说明书,逐项对军队《2008高频手术设备检测技术规范》提出修改建议。结果:现有检测技术规范中有一些检测参数的设置有歧义,判断指标制订也不完善。结论:修改后的检测技术规范更为严谨,更适应高频电刀的检测应用实际。

Objective To ensure the safety of high frequency surgical equipment in clinical applications,to have effective control the accuracy of safe parameters and operation data and to establish a reasonable detection technical specification.Methods Reference GB 9706.4-1999 ＂Medical electrical equipment-Part 2： Particular requirements for the safety of high frequency surgical equipment＂,combined with the instruction book of high-frequency electric knife,presented the suggestion to amend term by term on the 2008 high-frequency operation equipment test specification which was used in military.Results There were discrepancies in the test parameter setting of test technology regulation.And the formulation of estimation target was not perfect.Conclusion The modified specification is more rigorous for testing,and it is better in actual application of high frequency electric knife.