ISO 21534-2007 非有源外科植入物.关节置换植入物.特殊要求
时间:2024-05-10 21:28:35 来源: 标准资料网 作者：标准资料网 阅读：8868
【英文标准名称】:Non-activesurgicalimplants-Jointreplacementimplants-Particularrequirements
【原文标准名称】:非有源外科植入物.关节置换植入物.特殊要求
【标准号】:ISO21534-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-10
【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】:人工器官;骨粘接剂;陶瓷;检验;结构细节;制造日期;定义;设计;精密机械;精整;功能可靠性;功能性;功能;铰链;外科植入物;钝性的;信息;关节置换;连接件;关节;作标记;材料;医疗设备;医学科学;金属;骨接合术;包装件;塑料;生产;规范(验收);灭菌;外科学;测试
【英文主题词】:Alloys;Applications;Artificialorgans;Biologicalhazards;Bodies;Bonecements;Ceramics;Checks;Clinical;Constructiondetails;Contact;Dataofthemanufacturer;Definitions;Design;Evaluations;Finemechanics;Finishes;Functionalreliability;Functionality;Functions;Hinges;Implants(surgical);Inactive;Information;Jointreplacement;Joints;Joints(anatomy);Letterings;Marking;Materials;Measurement;Measuringtechniques;Medicaldevices;Medicalequipment;Medicalsciences;Metals;Osteosyntheses;Packages;Plastics;Polishing;Position;Production;Replacement;Roughness(surface);Specification(approval);Sterilization(hygiene);Surfaces;Surgery;Surgicalimplants;Testing;Topography
【摘要】:ThisInternationalStandardspecifiesparticularrequirementsfortotalandpartialjointreplacementimplants,artificialligamentsandbonecement,hereafterreferredtoasimplants.ForthepurposesofthisInternationalStandard,artificialligamentsandtheirassociatedfixingdevicesareincludedintheterm"implant".Itspecifiesrequirementsforintendedperformance,designattributes,materials,designevaluation,manufacturing,sterilization,packagingandinformationtobesuppliedbythemanufacturer.SometestsrequiredtodemonstrateconformancetothisInternationalStandardarecontainedinorreferencedinlevel3standards.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:13P;A4
【正文语种】:英语
【英文标准名称】:Materialsandarticlesincontactwithfoodstuffs-Plasticssubstancessubjecttolimitation-Determinationof1,3-benzenedimethaneamineinfoodsimulants
【原文标准名称】:与食品接触的材料和物品.受限制的塑料物质.食品模拟物中1,3-benzenedimethaneamine的测定
【标准号】:BSDDCEN/TS13130-12-2005
【标准状态】:现行
【国别】:英国
【发布日期】:2005-09-16
【实施或试行日期】:2005-09-16
【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】:乙酸;分析;物品;苯二甲胺;色谱法;触点;测定;含量测定;酒精;食品检验;食品包装;食品;高效液相色谱分析法;研究;接触食品的材料;材料规范;材料测试;迁移;迁移值;单体;橄榄油;塑料;溶解度;试件;测试
【英文主题词】:Aceticacid;Analysis;Articles;Benzenedimethanamine;Chromatography;Contact;Determination;Determinationofcontent;Ethanol;Foodinspection;Foodpackages;Foodproducts;HPLC;Investigations;Materialsincontactwithfood;Materialsspecification;Materialstesting;Migration;Migrationvalue;Monomers;Oliveoil;Plastics;Solubility;Testpieces;Testing
【摘要】:Thisdocument,partofEN13130,specifiesaprocedureforthedeterminationof1,3-benzenedimethanamine(alsoknownas3-(aminomethyl)-benzylamineorm-xylylenediamine(m-XDA))monomer,hereinafterreferredtoasm-XDA,inthefoodsimulantswater,3%w/vaqueousaceticacid,15%v/vaqueousethanolandoliveoil.Thelevelofm-XDAmonomerdeterminedisexpressedasmilligramsofm-XDAperkilogramoffoodsimulantintheabovementionedfoodsimulants.NOTEInadditiontotheinstabilityofm-XDAobservedinoliveoil,thetestlaboratorycouldnotdetectanym-XDApeakfromtheoliveoilwork-upprocedure.Basedonsomecontrolchecks,theassumptionofthetestlaboratorywasthattheextractionfromtheoliveoildoesnotwork.Therefore,itisrecommendedthatthefoodsimulant95%ethanoloriso-octanebeappliedassubstitutefattysimulantsinsteadofoliveoil.Itisbelievedthat95%ethanolandiso-octanecanbetreatedinthesamewayas15%v/vaqueousethanolandoliveoilsimulant,respectively.Correspondinginvestigationswerenotpossiblewithintheproject.
【中国标准分类号】:X08
【国际标准分类号】:67_250
【页数】:18P;A4
【正文语种】:英语
【英文标准名称】:Reedswitches-Part1:Genericspecification(IEC62246-1:2011);GermanversionEN62246-1:2011
【原文标准名称】:簧片开关.第1部分:总规范(IEC62246-1:2011).德文版EN62246-1-2011
【标准号】:DINEN62246-1-2011
【标准状态】:现行
【国别】:德国
【发布日期】:2011-12
【实施或试行日期】:2011-12-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Contactrelays;Contactunits;Definitions;Dry;Electriccontacts;Electricalengineering;Genericspecification;Measurement;Measuringtechniques;Mercurywetted;Protectivetubes;Quality;Qualityassessment;Reedcontact;Reedcontactunit;Reedrelays;Reedswitches;Relays;Specification;Testing
【摘要】:
【中国标准分类号】:K31
【国际标准分类号】:29_120_70
【页数】:81P;A4
【正文语种】:德语