BS EN ISO 10993-9-2009-05 医疗器械的生物学评价.潜在降解产物的识别和定量框架

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【英文标准名称】:Frameworkforidentificationandquantificationofpotentialdegradationproducts
【原文标准名称】:医疗器械的生物学评价.潜在降解产物的识别和定量框架
【标准号】:BSENISO10993-9-2009-05
【标准状态】:作废
【国别】:英国
【发布日期】:2009-06-30
【实施或试行日期】:2009-06-30
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Bioassay;Biochemicals;Biodegradability;Biology;Decompositionproducts;Definitions;Degradation;Deterioration;Determination;Evaluations;Identification;Medicaldevices;Medicalproducts;Medicaltechnology;Quantification
【摘要】:ThispartofISO10993providesgeneralprinciplesforthesystematicevaluationofthepotentialandobservedbiodegradationofmedicaldevicesandforthedesignandperformanceofbiodegradationstudies.ThispartofISO10993isnotapplicableto:a)viable-tissueengineeredproducts;b)methodologiesforthegenerationofdegradationproductsbymechanicalprocesses.Methodologiesfortheproductionofthistypeofdegradationproductaredescribedinspecificproductstandards,whereavailable;c)leachablecomponentswhicharenotdegradationproducts.Whereproductstandardsprovideapplicableproduct-specificmethodologiesfortheidentificationandquantificationofdegradationproducts,thosestandardsshallbeconsideredasalternatives.
【中国标准分类号】:
【国际标准分类号】:11_100_20
【页数】:18P.;A4
【正文语种】:英语


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【英文标准名称】:StandardTestMethodforMeasurementofThicknessofTransparentorOpaqueCoatingsbyDouble-BeamInterferenceMicroscopeTechnique
【原文标准名称】:双束干涉显微技术测量透明涂层或不透明涂层厚度的标准试验方法
【标准号】:ASTMB588-1988(2010)
【标准状态】:现行
【国别】:
【发布日期】:1988
【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】:B08.10
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:铝覆层;阳极镀层;铬电镀;覆层厚度;电解镀层;金属涂覆;透明涂层
【英文主题词】:Aluminumcoatings;Anodiccoatings;Chromiumelectroplating;Coatingthickness;Electrodepositedcoatings;Metalliccoatings;Transparentcoatings
【摘要】:Thethicknessofacoatingisoftencriticaltoitsperformance.Forsomecoating-substratecombinations,theinterferencemicroscopemethodisareliablemethodformeasuringcoatingthickness.Thistestmethodissuitableforspecificationacceptance.1.1Thistestmethodcoversthemeasurementofthethicknessoftransparentmetaloxideandmetalliccoatingsbyutilizingadouble-beaminterferencemicroscope.1.2Thetestmethodrequiresthatthespecimensurfaceorsurfacesbesufficientlymirrorliketoformrecognizablefringes.1.3Thistestmethodcanbeusednondestructivelytomeasure1to10x03BC;mthicktransparentcoatings,suchasanodiccoatingsonaluminum.Thetestmethodisuseddestructivelyfor0.1to10x03BC;mthickopaquecoatingsbystrippingaportionofthecoatingandmeasuringthestepheightbetweenthecoatingandtheexposedsubstrate.Thestrippingmethodcanalsobeusedtomeasure0.2to10x03BC;mthickanodiccoatingsonaluminum.1.4Thetestmethodisusableasareferencemethodforthemeasurementofthethicknessoftheanodicfilmonaluminumorofmetalliccoatingswhenthetechniqueincludescompletestrippingofaportionofthecoatingwithoutattackofthesubstrate.Foranodicfilmsonaluminum,thethicknessmustbegreaterthan0.4x03BC;m;theuncertaintycanbeasgreatas0.2x03BC;m.Formetalliccoatings,thethicknessmustbegreaterthan0.25x03BC;m;theuncertaintycanbeasgreatas0.1x03BC;m.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A29
【国际标准分类号】:17_040_20
【页数】:5P.;A4
【正文语种】:


【英文标准名称】:Recommendedpracticefordesignofreliableindustrialandcommercialpowersystems
【原文标准名称】:可靠的工业及商业电力系统设计用推荐规程
【标准号】:IEEE493-1997
【标准状态】:作废
【国别】:美国
【发布日期】:1997
【实施或试行日期】:
【发布单位】:美国电气电子工程师学会(IEEE)
【起草单位】:IEEE
【标准类型】:()
【标准水平】:()
【中文主题词】:工业设施;可靠性分析;发电厂;基础;电网;工业设备;电能;电气工程;维修;定义;定义;设计
【英文主题词】:Basis;Definition;Definitions;Design;Electricenergy;Electricpowernetworks;Electricalengineering;Industrialfacilities;Industrialplants;Maintenance;Powergeneratingplant;Reliabilityanalysis
【摘要】:
【中国标准分类号】:F21
【国际标准分类号】:29_240_01;91_140_50
【页数】:513P;A4
【正文语种】:英语