【英文标准名称】:Sterilizationofmedicaldevices-Informationtobeprovidedbythemanufacturerfortheprocessingofresterilizablemedicaldevices
【原文标准名称】:医疗器械的消毒.生产商提供的可再消毒医疗器械的处理信息
【标准号】:BSENISO17664-2004
【标准状态】:现行
【国别】:英国
【发布日期】:2004-03-12
【实施或试行日期】:2004-03-12
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:清洁处理;操作程序;消毒物品;绝育;自加工;定义;特性记述;消毒;规范;灭菌器;监督(认可);重新使用;证实;去污染;规范(验收);消毒能力;制造日期;危险分析;包装件;灭菌;保健;处理;企业;消费者与供货者的关系;医疗产品;产品信息;说明书;医疗设备;卫生学
【英文主题词】:
【摘要】:ISO17664:2004specifiestheinformationtobeprovidedbythemedicaldevicemanufacturerontheprocessingofmedicaldevicesclaimedtoberesterilizable,andmedicaldevicesintendedtobesterilizedbytheprocessor.ISO17664:2004specifiesrequirementsfortheinformationtobeprovidedbythemedicaldevicemanufacturer,sothatthemedicaldevicecanbeprocessedsafelyandwillcontinuetomeetitsperformancespecification.Requirementsarespecifiedforprocessingthatconsistsofallorsomeofthefollowingactivities:a)preparationatthepointofuse;b)preparation,cleaning,disinfection;c)drying;d)inspection,maintenanceandtesting;e)packaging;f)sterilization;g)storage.Whenprovidinginstructionsfortheseactivities,medicaldevicemanufacturersareexpectedtobeawareofthetrainingandknowledgeofprocedures,andoftheprocessingequipmentavailabletothepersonslikelytoberesponsibleforprocessing.Itislikelythatsomeprocessingprocedureswillbegenericandwellknownandwilluseequipmentandconsumablesconformingtorecognizedstandards.Inthiscase,areferenceintheinstructionsisallthatisrequired.Forthosemedicaldeviceswhereinstructionsforusearenotrequiredtoaccompanythemedicaldevice,othermeansofcommunicatingtheinformationcanbeused,e.g.usermanuals,symbolsorwallchartssuppliedseparately.TheprinciplesofISO17664:2004maybeappliedwhenconsideringtheinformationtobesuppliedwithmedicaldeviceswhichonlyrequiredisinfectionpriortore-use.ISO17664:2004isnotapplicabletotextiledevicesusedinpatient-drapingsystemsorsurgicalclothing.
【中国标准分类号】:C30
【国际标准分类号】:11_080_01
【页数】:26P;A4
【正文语种】:英语


【英文标准名称】:StandardTestMethodforDeterminingtheEffectivenessofMembraneSwitchESDShielding
【原文标准名称】:测定薄膜开关ESD屏蔽有效性的标准试验方法
【标准号】:ASTMF1812-2002
【标准状态】:现行
【国别】:
【发布日期】:2002
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F01.18
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:试验方法;可行性;开关;防护屏;静电学;薄膜开关;放电
【英文主题词】:ESD;membraneswitch;shielding
【摘要】:NearlyallelectronicdevicesaresusceptibletopossibledamageordegradationfromESDencounteredintheiroperatingenvironments.Thesensitivityoftheequipment,thepotentialconsequencesofamalfunction,andtheexpectedenvironmentalconditionsallimpactthelevelofESDprotectionneeded.ESDshieldingeffectivenesstestmaybedestructive,andunitsthathavebeentestedshouldbeconsideredunreliableforfutureuse.1.1Thistestmethodisusedtodeterminetheelectrostaticdischarge(ESD)shieldingeffectivenessofamembraneswitchassembly.Thistestmethodmaybeusedtotestamembraneswitchtodestruction,thatis,todetermineitsmaximumESDshieldingeffectiveness,oritmaybeusedtotesttheabilityofamembraneswitchtowithstandapredeterminedlevelofexposure.1.2ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:K31
【国际标准分类号】:31_220_20
【页数】:2P.;A4
【正文语种】: