【正版授权】 IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV EN-FR Medical electrical equipment - Part 2-44: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor

IEC60601-2-44:2009+AMD1:2012+AMD2:2016CSVEN-FRMedicalelectricalequipment-Part2-44:ParticularrequirementsforthebasicsafetyandessentialperformanceofX-rayequipmentforcomputedtomographyisastandardthatspecifiesthebasicsafetyandessentialperformancerequirementsforX-rayequipmentusedincomputedtomography(CT).ItisintendedforusebymedicaldevicemanufacturersandregulatoryauthoritiestoensurethatX-rayequipmentusedinCTmeetscertainstandardsofsafetyandperformance.

Thestandardspecifiesvariousrequirementssuchas:

*SafetyrequirementsfortheX-rayequipment,includingradiationprotection,electricalsafety,andmechanicalstability.

*Basicperformancerequirementssuchasimagequality,scantime,andradiationdose.

*Requirementsforensuringcompatibilitywithothermedicalequipmentandpatientdatasystems.

Tocomplywiththisstandard,manufacturersmustensurethattheirX-rayequipmentmeetsalloftheserequirementsandistestedandcertifiedaccordingly.Regulatoryauthoritiesalsoreviewandinspecttheequipmenttoensurecompliancewiththestandard.

CSVEN-FRindicatesthatthisstandardispublishedinFrenchandisharmonizedwiththeEuropeanUnion(EU)directiveandregulation.Thisstandardalsoprovidesadditionalclarificationsandamendmentstopreviousversionsofthestandardtoaddressanytechnicalupdatesorchangesintheindustry.

IEC60601-2-44:2009+AMD1:2012+AMD2:2016标准对CT用的X射线设备的基安全性与基本性能有具体要求，包括辐射防护、电气安全和机械稳定性等。制造商和监管机构需确保遵守该标准以确保CT使用的X射线设备满足一定的安全和性能标准。该标准还规定了与其他医疗设备和患者数据系统的兼容性要求，并规定了用于确保符合该标准的测试和认证要求。该标准是欧洲标准化委员会（EN）的一部分，其格式为CSV（