60601-2-64-2015

Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment


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标准号
60601-2-64-2015
发布日期
2015年05月01日
实施日期
2015年06月19日
废止日期
中国标准分类号
/
国际标准分类号
/
发布单位
CENELEC - European Committee for Electrotechnical Standardization
引用标准
61
适用范围
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LIGHT ION BEAM ME EQUIPMENT@ hereafter referred to as ME EQUIPMENT@ used for treatment of PATIENTS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only@ or to ME SYSTEMS only@ the title and content of that clause or subclause will say so. If that is not the case@ the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS@ as relevant. This particular standard@ with the inclusion of TYPE TESTS and SITE TESTS@ applies respectively to the manufacture and some installation aspects of LIGHT ION BEAM ME EQUIPMENT ?C intended for RADIOTHERAPY in human medical practice@ including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS)@ ?C that@ in NORMAL USE@ deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV to 500 MeV @ and ?C intended to be ?C for NORMAL USE@ operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application@ for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE@ ?C subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. NOTE 1 In this particular standard@ all references to installation refer to installation in the RESPONSIBLE ORGANIZATION'S premises. NOTE 2 In this particular standard@ all references to ABSORBED DOSE refer to ABSORBED DOSE in water. NOTE 3 Information regarding x-ray image guidance can be found in IEC 60601-2-68 (under development). NOTE 4 IEC 61217 gives guidance on the designation of ME EQUIPMENT movements@ the marking of scales@ their zero positions and the direction of movement with increasing value (see 201.7.4.101).




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