IEC/TR 60930-2008 管理、医疗、护理人员安全使用医疗电气设备和医疗电气系统用指南

标准号：IEC/TR 60930-2008
中文标准名称：管理、医疗、护理人员安全使用医疗电气设备和医疗电气系统用指南
英文标准名称：Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
标准类型：C47
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C47
国际标准分类号：11.040.01
引用标准：IEC 60601-1-2005;IEC 60601-1-2-2007;IEC 60601-1-8-2006;IEC 62353-2007
适用范围：This technical report is intended to lessen the RISK to PATIENTS, OPERATORS, and theirsurroundings by providing a code of safe application. This reduction of RISK is in addition tothat brought about by the RISK CONTROL measures incorporated in the MEDICAL ELECTRICALEQUIPMENT, the MEDICAL ELECTRICAL SYSTEM, and the electrical installation in medical locations,hereafter referred to as ME EQUIPMENT, ME SYSTEM and installation respectively.Not all existing ME EQUIPMENT, ME SYSTEMS or installations meet the requirements of therelevant lEG standards. From time to time, OPERATORS and RESPONSIBLE ORGANIZATIONS willencounter ME EQUIPMENT and ME SYSTEMS complying with older safety standards. However,the guidelines for safe application given in this technical report should nevertheless befollowed in so far as this is possible.The guidelines in this technical report can be used with ME EQUIPMENT or ME SYSTEMS for thehome healthcare environment provided the MANUFACTURER has included home use in theINTENDED USE or the CLINICAL ENGINEERING DEPARTMENT has checked that the electricalinstallation and the physical environment will not result in any unacceptable RISKS. Theseguidelines can also be applied to equipment used for compensation or alleviation of disease,injury or disability.If the ME EQUIPMENT, an ME SYSTEM or the installation does not comply with the relevant IECstandards, the RESPONSIBLE ORGANIZATION should consult with the CLINICAL ENGINEERINGDEPARTMENT or the MANUFACTURER for instructions on how to achieve an adequate level ofsafety.