ISO 15814-1999 外科植入物.聚合交脂基共聚物及混料.体外降解试验

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【英文标准名称】:Implantsforsurgery-Copolymersandblendsbasedonpolylactide-Invitrodegradationtesting
【原文标准名称】:外科植入物.聚合交脂基共聚物及混料.体外降解试验
【标准号】:ISO15814-1999
【标准状态】:现行
【国别】:国际
【发布日期】:1999-11
【实施或试行日期】:
【发布单位】:国际标准化组织(ISO)
【起草单位】:ISO/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:生理学试验;医学科学;定义;试验;在体外;塑料;外科植入物;机械试验;共聚物;医疗设备;降解;外科学;测试
【英文主题词】:physiologicaltests;medicalsciences;definitions;tests;invitro;plastics;surgicalimplants;mechanicaltesting;copolymers;medicalequipment;definition;degradation;surgery;testing
【摘要】:ThisInternationalStandardisapplicabletocopolymersand/orblendsbasedonpolylactide,inbulkorprocessedforms,usedforthemanufactureofsurgicalimplants.ThisInternationalStandarddescribesmethodsforthedeterminationofchemicalandmechanicalchangesinthepropertiesofthesecopolymersand/orblendsunderinvitrodegradationtestingconditions.ThetestmethodsspecifiedinthisInternationalStandardareintendedtodeterminethedegradationrateandthechangesinmaterialpropertiesofpolylactide-basedcopolymersand/orblendswithvariouscomonomers(forexampleglycolid,trimethylenecarbonate,ε-caprolactone)invitro.Theseinvitromethodscannotbeusedtopredictdefinitelythebehaviourofthesematerialsunderinvivoconditions.ThepurposeofthisInternationalStandardistocompareand/orevaluatematerialsorprocessingconditions.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:13P.;A4
【正文语种】:英语