【英文标准名称】:Biologicalevaluationofmedicaldevices-Part7:Ethyleneoxidesterilizationresiduals
【原文标准名称】:医疗装置用生物学评估.第7部分:环氧乙烷灭菌残留物
【标准号】:ANSI/AAMI/ISO10993-7-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【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】:生物分析和测试;生物试验;化学残余物;定义;牙科设备;环氧乙烷;评估;气相色谱法;气体的;保健;极限(数学);测量;医疗器械;医疗设备;医疗产品;医学科学;分析方法;质量保证;质量保证体系;残留物含量;残留物;规范(验收);灭菌技术;灭菌;灭菌气体;外科设备;外科植入物;外科器械;测试;证实
【英文主题词】:Biologicalanalysisandtesting;Biologicaltests;Chemicalresidues;Definition;Definitions;Dentalequipment;Ethyleneoxide;Evaluations;Gaschromatography;Gaseous;Healthprotection;Limits(mathematics);Measurement;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Methodsofanalysis;Qualityassurance;Qualityassurancesystems;Residualcontent;Residue;Residues;Specification(approval);Steriletechnology;Sterilization(hygiene);Sterilizinggases;Surgicalequipment;Surgicalimplants;Surgicalinstruments;Testing;Validation
【摘要】:ThispartofISO10993specifiesallowablelimitsforresidualethyleneoxide(EO)andethylenechlorohydrin(ECH)inindividualEO-sterilizedmedicaldevices,proceduresforthemeasurementofEOandECH,andmethodsfordeterminingcompliancesothatdevicesmaybereleased.Additionalbackground,includingguidanceandaflowchartshowinghowthisdocumentisapplied,arealsoincludedintheinformativeannexes.EO-sterilizeddevicesthathavenopatientcontact(e.g.,invitrodiagnosticdevices)arenotcoveredbythispartofISO10993.
【中国标准分类号】:C30
【国际标准分类号】:11_040
【页数】:
【正文语种】:英语


【英文标准名称】:Electricitymeteringequipment(a.c.).Acceptanceinspection.Part21:Particularrequirementsforelectromechanicalmetersforactiveenergy(classes0,5,1and2andclassindexesAandB)
【原文标准名称】:电量表设备(交流).验收检验.有功电能用机电计量仪的详细要求(0.5,1和2级,以及类指数A和B)
【标准号】:BSEN62058-21-2010
【标准状态】:现行
【国别】:英国
【发布日期】:2010-09-30
【实施或试行日期】:2010-09-30
【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】:验收;验收检验;验收试验;交流电流;交流瓦特电度表;计数器;电流表;直接连接;电气工程;电度表;供电表;机电的;企业;指示;计数检查;能耗测量;电功率测量;随机试样;样品试验;测试;测试条件;瓦时表
【英文主题词】:Acceptance;Acceptanceinspection;Acceptancetests;Alternatingcurrent;Alternating-currentmeters;Counters;Currentmeters;Directconnections;Electricalengineering;Electricitymeter;Electricitysupplymeters;Electromechanical;Enterprises;Indications;Inspectionbyattributes;Measurementofconsumption;Powermeasurement(electric);Randomsamples;Sampletests;Testing;Testingconditions;Watt-hourmeters
【摘要】:ThispartofIEC62058specifiesparticularrequirementsforacceptanceinspectionofnewlymanufactureddirectconnectedortransformeroperatedelectromechanicalmetersforactiveenergy(classes0,5,1and2)deliveredinlotsinquantitiesabove50.Themethodofacceptanceofsmallerlotsshouldbeagreeduponbythemanufacturerandthecustomer.Theprocessdescribedhereinisprimarilyintendedforacceptanceinspectionbetweenthemanufacturerandthepurchaser.ThisEuropeanstandardappliestometersofaccuracyclasses0,5,1and2,aswellastometersofclassindexesAandB.NOTEItcanalsobeusedforotherpurposes,forexampletosupportinitialverification.
【中国标准分类号】:N22
【国际标准分类号】:17_220_20;91_140_50
【页数】:28P.;A4
【正文语种】:英语