麻醉机法规清单[4P][169KB].pdf

《麻醉机法规清单[4P][169KB].pdf》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、序号适用法规/标准编号适用法规/标准名称Medicaldevices-Applicationofriskmanagementto1.ISO14971medicaldevicesInformationsuppliedbythemanufacturerwithmedical2.EN1041devicesGraphicalsymbolsforuseinthelabellingofmedical3.EN980devicesGraphicalsymbolsforelectricalequipmentinmedical4.IEC60878practiceMedicaldevices-Sym

2、bolstobeusedwithmedical5.ISO15223devicelabels,labelingandinformationtobesuppliedSIunitsandrecommendationsfortheuseoftheir6.ISO1000multiplesandofcertainotherunitsBiologicalevaluationofmedicaldevices-Part1:7.ISO10993-1EvaluationandtestingClinicalinvestigationofmedicaldevicesforhumanISO14155-1s

3、ubjects－Part1:Generalrequirements8.ISO14155-2Part2:ClinicalinvestigationplansEN60601-1MedicalElectricalEquipment,Part1:General9./IEC60601-1RequirementsforSafetyEN60601-1-1MedicalElectricalEquipment-Part1-1:General10.RequirementsforSafety-CollateralStandard:Safety/IEC60601-1-1requirementsform

4、edicalelectricalsystemsMedicalElectricalEquipment–Part1-2:GeneralEN60601-1-211.RequirementsforSafety-CollateralStandard:/IEC60601-1-2Electromagneticcompatibility-RequirementsandtestsEN60601-1-4MedicalElectricalEquipment-Part1-4:General12.RequirementsforSafety-CollateralStandard:/IEC60601-1-4

5、ProgrammableelectricalmedicalsystemsEN60601-1-6Medicalelectricalequipment-Part1-6:General13./IEC60601-1-6requirementsforsafety-Collateralstandard:UsabilityMedicalelectricalequipmentPart1-8:GeneralrequirementsforsafetyCollateralstandard:General14.IEC60601-1-8requirements,testsandguidanceforal

6、armsystemsinmedicalelectricalequipmentandmedicalelectricalsystemsFirstEditionAnestheticworkstationsandtheirmodules-Particular15.EN740requirementsTransportablegascylinders-Gascylinder16.EN1089-3identification(excludingLPG)-Part3:ColourcodingMedicalelectricalequipmentPart2.requirementsfor17.IE

7、C60601-2-13thesafetyofanestheticworkstationsInhalationalanaesthesiasystems-Part2:Anaesthetic18.ISO8835-2breathingsystemforadultsInhalationalanaesthesiasystems–Part3:Anaesthetic19.ISO8835-3gasscavengingsystems–TransferandreceivingsystemsInhalational