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ISO 15883-6-2011 垫圈-消毒器具.第6部分:非侵入式,非关键医疗设备和保健设备用的利用热消毒的垫圈-消毒器具的试验和要求

作者:标准资料网 时间:2024-05-14 18:41:15  浏览:8609   来源:标准资料网
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【英文标准名称】:Washer-disinfectors-Part6:Requirementsandtestsforwasher-disinfectorsemployingthermaldisinfectionfornon-invasive,non-criticalmedicaldevicesandhealthcareequipment
【原文标准名称】:垫圈-消毒器具.第6部分:非侵入式,非关键医疗设备和保健设备用的利用热消毒的垫圈-消毒器具的试验和要求
【标准号】:ISO15883-6-2011
【标准状态】:现行
【国别】:国际
【发布日期】:2011-04-15
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:清洁处理;清洁设备;清洁机;定义(术语);消毒设备;消毒;消毒器;加热效果;热学;实验室器具;实验室器皿;医疗设备;规范(验收);试验;热的
【英文主题词】:Cleaning;Cleaningequipment;Cleaningmachines;Definitions;Disinfectionapparatus;Disinfections;Disinfectors;Effectofheating;Heat;Laboratoryapparatus;Laboratoryware;Medicalequipment;Specification(approval);Testing;Thermal
【摘要】:WARNING—DevicesidentifiedwithinthescopeofISO15883-2,ISO15883-3andISO15883-4shallnotbeprocessedinwasher-disinfectorsspecifiedinthispartofISO15883.Examplesofmedicaldevicesthatarenottobeprocessedinthesedevicesincludepowereddevices,lumeneddevicesandotherinvasivedevices.ThispartofISO15883specifiesparticularrequirementsforwasher-disinfectors(WDs)intendedforusewhenthelevelofassuranceofdisinfectionthatisnecessarycanbeachievedbycleaningandthermaldisinfection(A0notlessthan60)anddoesnotrequireanindependentautomatedrecordofcriticalprocessestobekept.ItisintendedtobeusedinconjunctionwithISO15883-1,whichgivesgeneralrequirementsforWDs.TherangeofproductsonwhichWDsofthisparticulartypecanbeusedisrestrictedtodevicesandequipmentwhicharenon-invasiveandnon-critical(i.e.notpenetratingskinorcontactingmucosalsurfaces).NOTEThermaldisinfectioncanbeachievedbyrinsingtheloadwithhotwater,exposuretosteamorcombinationofthetwo.
【中国标准分类号】:C47
【国际标准分类号】:11_080_10
【页数】:14P.;A4
【正文语种】:英语


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MIL-STD-794E (NOTICE 1), MILITARY STANDARD: PARTS AND EQUIPMENT, PROCEDURES FOR PACKAGING OF (28 APR 1989) [S/S BY MIL-STD-2073-1]., MIL-STD-794E, dated 16 July 1982, is Inactive for new design. New design should use MIL-STD-2073-1, "Materiel, Procedures for Development and Application of Packaging Requirements."

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