【英文标准名称】:StandardGuideforSiliconeElastomers,GelsandFoamsUsedinMedicalApplicationsPartI-FormulationsandUncuredMaterials
【原文标准名称】:医疗设施中用的硅弹性体、凝胶和泡沫的标准指南.第I部分:组成和未硫化材料
【标准号】:ASTMF2038-2000(2005)
【标准状态】:现行
【国别】:
【发布日期】:2000
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.11
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:elastomer;foam;gel;HCR;highconsistencyrubber;liquidsiliconerubber;LSR;moisturecure;medicaldevicematerial;peroxidecure;platinumcure;RTV
【摘要】:4.1Thisguideisintendedtoprovideguidanceforthespecificationandselectionofsiliconematerialsformedicaldeviceapplications.Siliconemanufacturerssupplyingmaterialstothemedicaldeviceindustryshouldreadilyprovideinformationregardingnon-proprietaryproductformulationtotheircustomerseitherdirectly,orthroughtheUSFDAmasterfileprogram.1.1Thisguideisintendedtoeducatepotentialusersofsiliconeelastomers,gelsandfoamsrelativetotheirformulationanduse.Itdoesnotprovideinformationrelativetosiliconepowders,fluids,andothersilicones.Theinformationprovidedisofferedtoguideusersintheselectionofappropriatematerials,afterconsiderationofthechemical,physicalandtoxicologicalpropertiesofindividualingredientsorby-products.Thisstandardoffersgeneralinformationaboutsiliconematerialstypicallyusedformedicalapplications.DetailonthecrosslinkingandfabricationofsiliconematerialsisfoundinPartIIofthisstandard.1.2Fabricationandpropertiesofelastomersiscoveredinthecompaniondocument,F604,PartII.Thismonographaddressesonlycomponentsofuncuredelastomers,gelsandfoams.1.3Siliconebiocompatibilityissuescanbeaddressedatseverallevels,butultimatelythedevicemanufacturermustassessbiologicalsuitabilityrelativetointendeduse.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.UsersarealsoadvisedtorefertoMaterialSafetyDataSheetsprovidedwithuncuredsiliconecomponents.1.5BiologicalandphysicalpropertiestendtobemorereproduciblewhenmaterialsaremanufacturedinaccordancewithacceptedqualitystandardssuchasANSIISO9001andcurrentFDAQualitySystemRegulations/GoodManufacturingPracticeRegulations.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:


【英文标准名称】:Metallictubeconnectionsforfluidpowerandgeneraluse.24compressionfittings
【原文标准名称】:流体动力装置及通用金属管接头.24℃压合接头
【标准号】:BSISO8434-1-1995
【标准状态】:作废
【国别】:英国
【发布日期】:1995-09-15
【实施或试行日期】:
【发布单位】:英国标准学会(BSI)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:尺寸;温度;角(几何学);管接头;钢;直径;名称与符号;压力;使用说明;等级(质量);压合接头;防松螺母;螺纹管接头;管道配件;安全系数;螺纹;额定值;不锈钢;螺母;铜合金;作标记;非合金钢
【英文主题词】:
【摘要】:
【中国标准分类号】:J15
【国际标准分类号】:23_100_30
【页数】:40P;A4
【正文语种】:英语