ANSI/AAMI/ISO 11663-2009 血液透析和相关疗法用透析液的质量

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【英文标准名称】:Qualityofdialysisfluidforhaemodialysisandrelatedtherapies
【原文标准名称】:血液透析和相关疗法用透析液的质量
【标准号】:ANSI/AAMI/ISO11663-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【实施或试行日期】:
【发布单位】:美国国家标准学会(US-ANSI)
【起草单位】:ANSI
【标准类型】:()
【标准水平】:()
【中文主题词】:血液;浓缩物;污染物;定义(术语);渗析;血液透析过滤器;血透析;液体;标志;医学科学;医疗技术学;纯度;质量;质量保证;质量要求;规范(验收)
【英文主题词】:Blood;Concentrates;Contamination;Definitions;Dialysis;Haemodiafiltration;Haemodialysis;Liquids;Marking;Medicalsciences;Medicaltechnology;Purity;Quality;Qualityassurance;Qualityrequirements;Specification(approval)
【摘要】:Specifiesminimumrequirementsfordialysisfluidsusedforhaemodialysisandhaemodiafiltration,includingsubstitutionsolutionforhaemodiafiltrationandhaemofiltration.Thisstandarddoesnotaddresstherequirementsforthewaterandconcentratesusedtopreparedialysisfluidortheequipmentusedinitspreparation.
【中国标准分类号】:C05;C45
【国际标准分类号】:11_040_20
【页数】:
【正文语种】:英语

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上一篇: ANSI/AAMI/ISO 11663(Ed1)-2009 血液透析和相关疗法用透析流体质量
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MIL-HDBK-772, MILITARY STANDARDIZATION HANDBOOK: MILITARY PACKAGING ENGINEERING (30 MAR 1981) [NO S/S DOCUMENT]., This document provides basic and fundamental packaging engineering principles and practices for the packaging of military supplies and equipment.【英文标准名称】:Implantsforsurgery-Minimumdatasetsforsurgicalimplants
【原文标准名称】:外科植入物.外科植入物的最小数据组
【标准号】:ISO16054-2000
【标准状态】:现行
【国别】:国际
【发布日期】:2000-12
【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/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:陶瓷;数据记录;定义;精密机械;外科植入物;信息交流;国际的;医学科学;烧结的;规范(验收);外科学
【英文主题词】:Ceramic;Ceramics;Datarecords;Definitions;Finemechanics;Implants(surgical);Informationexchange;International;Medicalsciences;Sintered;Specification(approval);Surgery;Surgicalimplants
【摘要】:ThisInternationalStandarddefinesminimumdatasetsforsurgicalimplantstofacilitaterecordingandinternationalexchangeofdataforthepurposesofimplantregistryandtrackingsystemsandforretrievalanalysis.Minimumdatacollectionrequirementsarespecifiedforthepurposeofimplanttrackingtoallowrecallforproductcorrectionorpa-tientfollowupintheeventofunforeseendevicemalfunction.Theminimumdatasetalsofulfilsthecoredatarequire-mentstoallowcrossreferencingbetweenextendeddatasetsforthepurposesofretrievalanalysisandresearch.ThisInternationalStandardisapplicabletothemanufacturersanddistributorsofmedicaldevicesintendedforper-manentimplant,i.e.morethan30daysandtothosehospitalsandothermedicalfacilitieswhichcarryoutimplantprocedures.Itspecifiesrequirementsfordataitemstoberecordedbythemanufacturersanddistributorsofperma-nentlyimplantablemedicaldevicesandbyhospitalsandothermedicalfacilitiesatboththetimeofimplantandatthetimeofanysubsequentexplantprocedure.ThisInternationalStandardisintendedtodefineaminimumdatasettoberecordedforallimplantandexplantevents,aswellasprovidingforthetimelyretrievalofminimumimplantdatarelatedtospecificsubsetsofpatientswhohavereceivedspecificidentifieddevicesordeviceswithinaspecifiedrangeoflot,batchorserialnumbers,forthepurposeofpatientfollowup.ItisnottheintentofthisInternationalStandardtoprovideameansofdatarecoverywhichisrelatedtospecificmedicalpractitioners,medicalfacilitiesormanufacturersforpurposesotherthanpatientfollowup.NOTEUsersofthisInternationalStandardshouldensurecompliancewithappropriatenationalstandardsorregulationscon-cerningdataprotectionandhandling.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】:英语

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ANSI/AAMI/ISO 11663-2009 血液透析和相关疗法用透析液的质量

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