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Medical electrical equipment. Medical light ion beam equipment. Performance characteristics 医用电气设备 医用光离子束设备 性能特征
发布日期: 2018-04-24
BS EN IEC 62667:2018适用于用于治疗目的的光离子束医用电气设备 人类医学实践。本文件适用于光离子束医用电气设备,该设备通过 每个核子的能量在10 MeV/n到500 MeV/n之间。本文件描述了由 光离子束医用电气设备制造商,但未规定验收试验。本文件规定了确定和披露性能的试验程序 特性,正确选择、应用和使用 轻离子束医用电气设备,并在随附文件中声明 文件以及特定条件下预期的最大偏差或变化 正常使用条件。中给出了性能值的表示格式 附录A.交叉引用:IEC 60601-2-1:2009 Ed 3EN 60580(采用IEC 60580:2000)EN 60601-2-64(IEC 60601-2-64:2014)ASIEC 60601-2-64:2014 ED1EN 60601-2-1(IEC 60601-2-1:2009+A1)ASIEC 60601-1:2005EN 60601-1 Amd 1(10/13)IEC ASIEC TR 60788:2004EN 61217(IEC 61217:2011)ASIEC 60601-2-1-1-1-1:2009/AMD1:2014EN 60601-1-1:2005 ASIEC 60601-1:ICRU:200585aIEC 62366-1:2015EN 60976(IEC 60976: 2007年)ASEN 60731(IEC 60731:2011)ASIEC 60601-1-2-11:2013IEC 60731:2011IEC 62220-1-1-1:1:1:2015EC 622-1-1-1-1-1:1)ec6.1.1.1)acec6.1.2007)acn(2007年)acn(2007年)asn 60731.7)acn 60731(2007)asn 60731.7.7.7.7.7.7.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1-1.1.1.1.1.1.1.1.1.1-1-1.1-1-1-1-1-1-1-1-1-1-1.1.1:1:1:IEC 62366-1:2015)ASIEC60976:2007EN 60601-2-68(IEC 60601-2-68:2014)ASIEC 60601-2-17:2013 ED3购买本文件时可使用的所有现行修订版均包含在购买本文件中。
BS EN IEC 62667:2018 applies to LIGHT ION BEAM ME EQUIPMENT when used, for therapy purposes, in human medical practice.This document applies to LIGHT ION BEAM ME EQUIPMENT which delivers LIGHT ION BEAMS with an ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n.This document describes measurements and test procedures to be performed by the MANUFACTURER of LIGHT ION BEAM ME EQUIPMENT but does not specify ACCEPTANCE TESTS.This document specifies test procedures for the determination and disclosure of performance characteristics, knowledge of which is necessary for proper selection, application, and use of LIGHT ION BEAM ME EQUIPMENT and which are to be declared in the ACCOMPANYING DOCUMENTATION together with the greatest deviation or variation to be expected under specific conditions in NORMAL USE. A format for presentation of performance values is given in Annex A.Cross References:IEC 60601-2-1:2009 Ed 3EN 60580 (IEC 60580:2000 Adopted)EN 60601-2-64 (IEC 60601-2-64:2014)ASIEC 60601-2-64:2014 ED1EN 60601-2-1 (IEC 60601-2-1:2009+A1) ASIEC 60601-1:2005EN 60601-1 Amd 1 (10/13) IEC ASIEC TR 60788:2004EN 61217 (IEC 61217:2011) ASIEC 60601-2-1:2009/AMD1:2014EN 60601-1 (IEC 60601-1:2005) ASIEC 60601-1:2005/AMD1:2012IEC 61217:2011IEC 60580:2000ICRU 33ICRU 85aIEC 62366-1:2015EN 60976 (IEC 60976:2007) ASEN 60731 (IEC 60731:2011) ASIEC 60601-2-11:2013IEC 60731:2011IEC 62220-1-1:2015EN 60601-2-11 (IEC 60601-2-11:2013)ASEN 61267 (IEC 61267:2005) ASEN 62220-1-1 (IEC 62220-1-1:2015) ASEN 61223-3-5 (IEC 61223-3-5:2004) ASIEC 62083:2009EN 62083 (IEC 62083:2009) ASIEC 61267:2005EN 60601-2-17 (IEC 60601-2-17:2013)ASIEC 61223-3-5:2004IEC 60601-2-68:2014 ED1EN 62366-1 (IEC 62366-1:2015) ASIEC 60976:2007EN 60601-2-68 (IEC 60601-2-68:2014) ASIEC 60601-2-17:2013 ED3All current amendments available at time of purchase are included with the purchase of this document.
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发布单位或类别: 英国-英国标准学会
关联关系
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