基本信息
| 标准名称： | 医用X射线设备包装、运输和贮存 |
| 英文名称： | Packaging，transportation and storage for medical X－ray equipment |
| 中标分类： |
医药、卫生、劳动保护 >>
医疗器械 >>
医用射线设备 |
| ICS分类： |
医药卫生技术 >>
医疗设备 >>
射线照相设备
|
| 替代情况： | 替代YY 91099-1999 |
| 发布部门： | 国家药品监督管理局 |
| 发布日期： | 2007-01-31 |
| 实施日期： | 2008-01-01 |
| 首发日期： | |
| 作废日期： | |
| 提出单位： | 国家药品监督管理局 |
| 归口单位： | 全国医用X线设备及用具标准化分技术委员会 |
| 起草单位： | 上海医疗器械厂有限公司、上海西门子医疗器械有限公司 |
| 起草人： | 袁菊芬、梅伟铭 |
| 出版社： | 中国标准出版社 |
| 出版日期： | 2007-05-01 |
| 页数： | 平装16开/页数：7/字数：9千字 |
| 书号： | 155066·2-17573 |
适用范围
本标准规定了医用X射线设备、附件及用具的包装、运输和贮存的要求、试验方法、检验规则；适用于医用X射线设备、附件及用具的包装、运输和贮存。
前言
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目录
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引用标准
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所属分类： 医药 卫生 劳动保护 医疗器械 医用射线设备 医药卫生技术 医疗设备 射线照相设备
【英文标准名称】:StandardGuideforAssessingMicrostructureofPolymericScaffoldsforUseinTissueEngineeredMedicalProducts
【原文标准名称】:组织工程医用产品用聚合物工作台的微观结构的评估的标准指南
【标准号】:ASTMF2450-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010
【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】:F04.42
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:microstructure;poresize;porevolume;porosity;porousmaterials;tissuescaffolds;Polymericscaffolds;Tissueengineeredmedicalproducts(TEMPs)
【摘要】:Theabilitytoculturefunctionaltissuetorepairdamagedordiseasedtissueswithinthebodyoffersaviablealternativetoxenograftsorheterografts.Usingthepatientx2019;sowncellstoproducethenewtissueofferssignificantbenefitsbylimitingrejectionbytheimmunesystem.Typically,cellsharvestedfromtheintendedrecipientareculturedinvitrousingatemporaryhousingorscaffold.Themicrostructureofthescaffold,thatis,itsporosity,themeansize,andsizedistributionofporesandtheirinterconnectivityiscriticalforcellmigration,growthandproliferation(AppendixX1).Optimizingthedesignoftissuescaffoldsisacomplextask,giventherangeofavailablematerials,differentmanufacturingroutes,andprocessingconditions.Allofthesefactorscan,andwill,affectthesurfacetexture,surfacechemistry,andmicrostructureoftheresultantscaffolds.Factorsthatmayormaynotbesignificantvariablesdependonthecharacteristicsofagivencelltypeatanygiventime(thatis,changesincellbehaviorduetothenumberofpassages,mechanicalstimulation,andcultureconditions).Tissuescaffoldsaretypicallyassessedusinganoverallvalueforscaffoldporosityandarangeofporesizes,thoughthedistributionofsizesisrarelyquantified.Publishedmeanporesizesanddistributionsareusuallyobtainedfromelectronmicroscopyimagesandquotedinthemicrometerrange.Tissuescaffoldsaregenerallycomplexstructuresthatarenoteasilyinterpretedintermsofporeshapeandsize,especiallyinthreedimensions.Therefore,itisdifficulttoquantifiablyassessthebatch-to-batchvarianceinmicrostructureortomakeasystematicinvestigationoftherolethatthemeanporesizeandporesizedistributionhasoninfluencingcellbehaviorbasedsolelyonelectronmicrographs(Tomlinsetal,(1)).Fig.1givesanindicationofpotentialtechniquesthatcanbeusedtocharacterizethestructureofporoustissuescaffoldsandthelengthscalethattheycanmeasure.Clearlyarangeoftechniquesmustbeutilizedifthescaffoldistobecharacterizedindetail.Theclassificationandterminologyofporesizes,suchasthosegiveninTable2,hasyettobestandardized,withdefinitionsoftermsvaryingwidely(asmuchasthreeordersofmagnitude)betweendifferingapplicationsandindustries.BothTable2andthesupportingdetaileddiscussionincludedwithinAppendixX2describedifferencesthatexistbetweenIUPAC(InternationalUnionofPureandAppliedChemistry)definitionsandthecommonterminologycurrentlyutilizedwithinmostlifescienceapplications,whichincludebothimplantandtissueengineeringapplications.Sincetheliteraturecontainsmanyothertermsfordefiningpores(Perretetal(3)),itisrecommendedthatthetermsusedbyauthorstodescribeporesbedefinedinordertoavoidpotentialconfusion.Additionally,sinceanyofthedefinitionsinTable2canshift,dependendingontheporesizedeterminationmethod(seeTable1andFig.1),anaccompanyingstatementdescribingtheutilizedassessmenttechniqueisessential.AllthetechniqueslistedinTable1havelimitationsforassessingcomplexporousstructures.Fig.2aandFig.2bshowathrough-andablind-endporerespectively.Porometrymeasurements(see7.4)areonlysensitivetothenarrowestpointalongavariablediameterthrough-poreandthereforecangivealowermeasureoftheporediameterthanotherinvestigativetechniques,suchasscanningelectronmicroscope(SEM),whichmaysampleatadifferentpointalongthepore.Thephysicalbasisofporometrydependsonthepassageofgasthroughthematerial.Therefore,thetechniqueisnotsensitivetoblind-endorclosedpore.......
【中国标准分类号】:G45
【国际标准分类号】:11_100
【页数】:10P.;A4
【正文语种】:英语