【英文标准名称】:Biologicalevaluationofmedicaldevices-Testsforgenotoxicity,carcinogenicityandreproductivetoxicity
【原文标准名称】:医疗器械的生物评定.遗传毒性、致癌性和生殖毒性试验
【标准号】:BSENISO10993-3-2003
【标准状态】:作废
【国别】:英国
【发布日期】:2003-10-31
【实施或试行日期】:2003-10-31
【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】:生物测定;生物试验;致癌物材料;致癌物质;定义;牙科设备;牙科器械;牙科材料;精密机械;遗传学;遗传毒性;材料;医疗设备;医疗产品;医学科学;生殖系统;外科设备;外科植入物;测试;毒性
【英文主题词】:Bioassay;Biological;Biologicalhazards;Biologicaltests;Carcinogenicmaterials;Carcinogens;Definitions;Dentalequipment;Dentalinstruments;Dentalmaterials;Evaluations;Finemechanics;Genes;Genetics;Genotoxicity;Implants(surgical);Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Methods;Preparation;Reproductions;Reproductivesystem;Samples;Surgicalequipment;Surgicalimplants;Testing;Toxicity
【摘要】:ISO10993-3:2003specifiesstrategiesforhazardidentificationandtestsonmedicaldevicesforthefollowingbiologicalaspects:genotoxicity,carcinogenicity,andreproductiveanddevelopmentaltoxicity.ISO10993-3:2003isapplicableforevaluationofamedicaldevicewhosepotentialforgenotoxicity,carcinogenicityorreproductivetoxicityhasbeenidentified.GuidanceonselectionoftestsisprovidedinISO10993-1.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:28P;A4
【正文语种】:英语


Product Code:SAE J1701
Title:Torque-Tension Tightening for Inch Series Fasteners
Issuing Committee:Fasteners Committee
Scope:This SAE Information Report is provided as an advisory guide. Individual application discretion is recommended. The content has been presented as accurately as possible, but responsibility for its application lies with the user. The document covers the variables in the torque-tension relationship: friction, materials, temperature, humidity, fastener and mating part finishes, surfaces, and the kind of wrenching employed.Also described in this document is the torque management required to achieve correct fastener joint tightening.The thread fit of fasteners must be in accordance with Class 2A for external and 2B for internal inch threads.