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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part13:Identificationandquantificationofdegradationproductsfrompolymericmedicaldevices
【原文标准名称】:医疗器械的生物学评价第13部分:聚合物医疗器械降解产物的定性与定量
【标准号】:ISO10993-13-1998
【标准状态】:作废
【国别】:国际
【发布日期】:1998-11
【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/TC194
【标准类型】:()
【标准水平】:()
【中文主题词】:识别;生物测定;定义;试验;医疗设备;高聚物;分解产物;变坏
【英文主题词】:Accelerated;Bioassay;Biologicaltests;Decomposition;Decompositionproducts;Definitions;Degradability;Degradation;Deterioration;Evaluations;Identification;Medicaldevices;Medicalequipment;Medicalproducts;Methods;Polymers;Quantification;Real-time;Screening-method;Specification(approval);Testing;Verification
【摘要】:ThispartofISO10993providesguidanceongeneralrequirementsforthedesignoftestsforidentifyingandquantifyingdegradationproductsfromfinishedpolymericmedicaldevicesreadyforclinicaluse.ThispartofISO10993describestwotestmethodstogeneratedegradationproducts,anaccelerateddegradationtestasascreeningmethodandareal-timedegradationtest.Formaterialswhichareintendedtopolymerizeinsitu,thesetorcuredpolymerisusedfortesting.Thedatageneratedareusedinthebiologicalevaluationofthepolymer.ThispartofISO10993considersonlythosedegradationproductsgeneratedbyachemicalalterationofthefinishedpolymericdevice.Itisnotapplicabletodegradationofthedeviceinducedduringitsintendedusebymechanicalstress,wearorelectromagneticradiation.ThebiologicalactivityofthedebrisandsolubledegradationproductsisnotaddressedinthispartofISO10993,butshouldbeevaluatedaccordingtotheprinciplesofISO10993-1andISO14538.Becauseofthewiderangeofpolymericmaterialsusedinmedicaldevices,nospecificanalyticaltechniquesareidentifiedorgivenpreference.NospecificrequirementsforacceptablelevelsofdegradationproductsareprovidedinthispartofISO10993.
【中国标准分类号】:C30
【国际标准分类号】:11_040_01;11_100_20
【页数】:10P;A4
【正文语种】:英语


【英文标准名称】:Waterquality-Determinationofselectedelementsbyinductivelycoupledplasmaopticalemissionspectrometry(ICP-OES)
【原文标准名称】:水质.感应耦合等离子体光学发射光谱法(ICP-OES)测定选取的元素
【标准号】:ISO11885-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-08
【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/TC147
【标准类型】:()
【标准水平】:()
【中文主题词】:AES;铝;分析;锑;砷;原子发射光谱法;钡;铍;铋;硼;镉;钙;阳离子;化学分析和测试;水化学;铬;钴;含量测定;铜;定义;检定极限;测定;元素;发射光谱测定法;污泥检验;废水检验;镓;ICP;铟;研究方法;铁;铅;锂;镁;锰;金属含量;金属;钼;镍;OES;光学发射光谱法;磷;等离子体;钾;硒;污水;硅;银;污泥;钠;光谱化学分析;标准方法;锶;硫;地表水;测试;锡;钛;钨;钒;水;水常规;水常规(实验);水质;水质测试;波长;锌;锆
【英文主题词】:AES;Aluminium;Analysis;Antimony;Arsenic;Atomicemissionspectrometry;Barium;Beryllium;Bismuth;Boron;Cadmium;Calcium;Cations;Chemicalanalysisandtesting;Chemicalelements;Chemistryofwater;Chromium;Cobalt;Contentdetermination;Copper;Definitions;Detectionlimits;Determination;Determinationofcontent;Elements;Emissionspectrophotometry;Examinationofsludge;Examinationofwastewater;Gallium;ICP;Indium;Inter-laboratorytests;Investigationmethods;Iron;Lead;Lithium;Magnesium;Manganese;Massconcentration;Metalcontent;Metals;Methodsofanalysis;Molybdenum;Nickel;OES;OpticalEmissionSpectroscopy;Phosphorus;Plasma;Potassium;Quantification;Selenium;Sewage;Silicon;Silver;Sludge;Sodium;Spectrochemicalanalysis;Spectrometry;Standardmethods;Strontium;Sulphur;Surfacewater;Testing;Tin;Titanium;Tungsten;Vanadium;Water;Waterpractice;Waterquality;Watertesting;Wavelengths;Zinc;Zirconium
【摘要】:ThisInternationalStandardspecifiesamethodforthedeterminationofdissolvedelements,elementsboundtoparticles("particulate")andtotalcontentofelementsindifferenttypesofwater(e.g.ground,surface,raw,potableandwastewater)forthefollowingelements:aluminium,antimony,arsenic,barium,beryllium,bismuth,boron,cadmium,calcium,chromium,cobalt,copper,gallium,indium,iron,lead,lithium,magnesium,manganese,molybdenum,nickel,phosphorus,potassium,selenium,silicon,silver,sodium,strontium,sulfur,tin,titanium,tungsten,vanadium,zincandzirconium.Takingintoaccountthespecificandadditionallyoccurringinterferences,theseelementscanalsobedeterminedindigestsofwater,sludgesandsediments(forexample,digestsofwaterasspecifiedinISO15587-1orISO15587-2).Themethodissuitableformassconcentrationsofparticulatematterinwastewaterbelow2g/l.Thescopeofthismethodmaybeextendedtoothermatricesortohigheramountsofparticulatematterifitcanbeshownthatadditionallyoccurringinterferencesareconsideredandcorrectedforcarefully.Itisuptotheusertodemonstratethefitnessforpurpose.Recommendedwavelengths,limitsofquantificationandimportantspectralinterferencesfortheselectedelementsaregiveninTable1.
【中国标准分类号】:Z16
【国际标准分类号】:13_060_50
【页数】:28P;A4
【正文语种】:英语