IEC 62353:2007 医疗电气设备 - 医疗电气设备维修后的经常性试验和试验

标准编号：IEC 62353:2007

中文名称：医疗电气设备 - 医疗电气设备维修后的经常性试验和试验

英文名称：Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

发布日期：2007-05-15

标准范围

适用于医用电气设备和医用电气系统，以下简称医用电气设备和医用电气系统，或符合IEC 60601-1的此类设备或系统的部件在投入使用前、维护、检查期间的测试，维修和维修后，或在评估此类医用电气设备或医用电气系统或其部件安全性的反复试验时。对于未按照IEC 60601-1制造的设备，考虑到设计安全标准和设备使用说明中的信息，可以使用这些要求。本标准包含与IEC 60601-1不同版本相关的允许值表。就本标准而言，测量方法的应用与医用电气设备或医用电气系统的设计版本无关。本标准包括:-“一般要求”，其中包含普遍关注的条款，以及-“特殊要求”，涉及特殊类型医用电气设备或医用电气系统的进一步条款，适用于“一般要求”。本标准也适用于修理后的试验。测试应根据所执行的工作范围和制造商的适用指南进行定义。

Applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as me equipment and me systems, or parts of such equipment or systems, which comply with IEC 60601-1, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such me equipment or me systems or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment.This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the me equipment or me system is designed.This standard contains:- "general requirements", which contain clauses of general concern, and- "particular requirements", further clauses handling special types of me equipment or me systems and applying in connection with the "General requirements".This standard is also applicable to tests after repair. The testing shall be defined according to the extent of work performed and applicable guidance from the manufacturer.

标准预览图