IEC-1-3.ppt

IEC-1-3.ppt

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MedicalelectricalequipmentPart1:

Generalrequirementsforsafety3-Collateralstandard:

GeneralrequirementsforradiationprotectionindiagnosticX-rayequipment（GB9706.12-1997医用电气设备第一部分:

安全通用要求三并列标准诊断X射线设备辐射防护通用要求）Claim本PPT中引用的材料仅供学习法规之用,本人对材料的真实性不负任何责任.同时对引用材料的提供者表示感谢.请尊重相关公司的权益.X-rayoverviewX射线是一种波长极短，能量很大电磁波，它除了具有可见光的一般性质外，还具有自身的一些特性，即穿透作用、电离作用、感光作用、荧光作用及生物效应等。

X射线在医学上的应用有三个方面的内容，即X射线诊断、X射线治疗及X射线防护。

用于诊断的X射线机称为诊断X射线机，可以作透视、摄影检查。

X射线透视主要依据的是X射线的穿透作用，差别吸收及荧光作用；X射线摄影依据的是X射线的穿透作用，差别吸收及感光作用。

CT依据的是射线的穿透作用，差别吸收及荧光作用（或电离，根据检测器不同）本标准涉及的是X射线防护。

X射线的确定性效应（见背景资料）X射线的随机效应（见背景资料）GeneralprinciplesforX-rayprotection距离防护。

就是尽可能远离射线源。

时间防护。

就是尽可能减少可能受到射线照射的时间。

屏蔽防护。

就是在射线源的周围设置能够吸收或阻挡射线的物体（称为屏蔽物），尽可能减弱射线到达人体时的强度和能量。

最常用的有铝、铁、铅、混凝土等。

加强剂量监测。

保证射线源安全运行，避免各种人为事故的发生。

ICRP的建议:

Thejustificationofapractice.实践正当性Theoptimizationofprotection.防护最优化Individualdoseandrisklimits。

个体剂量和风险限制受检者所受的医疗照射,应遵循放射实践的正当性和放射防护的最优化原则,避免一切不必要的照射,对确实具有正当理由需要进行的医用X射线诊断检查,必须在获取所需诊断信息的同时,把受检者剂量控制到可以合理达到的尽可能低水平。

对操作者或其他人员也适用。

防护要求的趋势：

越来越严格。

X-raytypicalapplicationX-RayEmissionIdealX-rayCharacteristic点状X射线源单能X射线穿透能力高斯分布特性X-RaySpectrumX-RayItensityU2IGeneratorshouldhaverippleaslowaspossible.29.201RadiationQuality29.201.1Limitationofoperatingvoltageindentalapplications29.201RadiationQuality29.201.2Half-valuelayersinX-rayequipment29.201RadiationQuality29.201.3FiltrationinX-raytubeassemblies29.201RadiationQuality29.201.4FiltrationinX-raysourceassemblies29.201RadiationQuality29.201.5TotalfiltrationinX-rayequipment29.201RadiationQuality29.201.6IndicationofFilterproperties29.201RadiationQuality29.201.7TestforFiltrationbyirremovablematerials29.201RadiationQuality29.201.8TestforAddedfiltersandmaterials29.201.9TestforHalf-valuelayer29.202LimitationandindicationoftheextentoftheX-raybeaml29.202.1EnclosureofX-raytubes29.202LimitationandindicationoftheextentoftheX-raybeaml29.202.2LimitingDIAPHRAGMinX-raytubeassemblies29.202LimitationandindicationoftheextentoftheX-raybeaml29.202.3ConfinementofExtra-focalradiation29.202LimitationandindicationoftheextentoftheX-raybeaml29.202.4MethodofbeamlimitationinX-rayequipment29.202LimitationandindicationoftheextentoftheX-raybeaml29.202.5Indicationontheequipment29.202LimitationandindicationoftheextentoftheX-raybeaml29.202.6IndicationintheInstructionforuse29.202LimitationandindicationoftheextentoftheX-raybeaml29.202.7Indicationbylightfield-indicatori1i2i3i41mDistancefromfocalspot/距焦点处1m29.202LimitationandindicationoftheextentoftheX-raybeaml29.202.8Accuracyofmarkedandwrittenindications29.202LimitationandindicationoftheextentoftheX-raybeaml29.202.9Accuracyofindicationwithalightfield-indicatorlightfield29.203RelationshipbetweenX-rayfieldandimagereceptionarea29.203.1positioningofthereferenceaxis29.203RelationshipbetweenX-rayfieldandimagereceptionarea29.203.2Focalspottoimagereceptordistance29.203RelationshipbetweenX-rayfieldandimagereceptionarea29.203.3InterceptionoftheX-raybeaminRadioscopy29.203RelationshipbetweenX-rayfieldandimagereceptionarea29.203.4CorrespondencebetweenX-rayfieldandimagereceptorareaX-rayfieldImagereceptorAreaX射线强度分布29.204Leakageradiation29.204.1MountingoftheX-raysourceassemblies29.204Leakageradiation29.204.2Statementofreferenceloadingconditions29.204Leakageradiation29.204.3Leakageradiationinloadingconditions29.204Leakageradiation29.204.4Leakageradiationduringloadingforvoltage-adjustments29.204Leakageradiation29.204.5Leakageradiationwhennotinloadingstate29.205Focalspottoskindistance29.205.1X-rayequipmentforradioscopy29.205Focalspottoskindistance29.205.2X-rayequipmentforradiography29.205Focalspottoskindistance20.205.3InformationintheAccompanyingdocumentsX-rayreduction29.206AttenuationoftheX-raybeam29.206.1AttenuationbyitemsinX-raybeam29.206AttenuationoftheX-raybeam29.206.2InformationintheAccompanyingdocuments29.206AttenuationoftheX-raybeam29.206.3Testforattenuation29.207Primaryprotectiveshielding29.207.1Requirements29.207Primaryprotectiveshielding29.207.2TestattenuationofResidualradiation29.207Primaryprotectiveshielding29.207.3Testattenuationequivalent29.208Protectionagainststrayradiation29.208.1protectionbydistance29.208Protectionagainststrayradiation29.208.2Controlfromaprotectedarea29.208Protectionagainststrayradiation29.208.3DesignatedSignificantzoneofoccupancy29.208Protectionagainststrayradiation29.208.4Significantzoneofoccupancywithlimitedstrayradiation29.208Protectionagainststrayradiation29.208.5Handgripsandcontroldevices29.208Protectionagainststrayradiation29.208.6TestforstrayradiationIEC60601-1-32ndEditionFocusongeneralrequirementsforRADIATIONPROTECTIONrequi