ASTM F1441-2003(2009) 人体软组织扩张器具的标准规范
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【英文标准名称】:StandardSpecificationforSoft-TissueExpanderDevices
【原文标准名称】:人体软组织扩张器具的标准规范
【标准号】:ASTMF1441-2003(2009)
【标准状态】:现行
【国别】:美国
【发布日期】:2003
【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】:F04.32
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:elastomer;expander;implant;implantmaterial;medicaldevice;plasticsurgery;softtissueexpander;Expanderdevices;Orthopaedicmedicaldevices--specifications;Softtissueimplantmaterials
【摘要】:Thisspecificationcontainsrequirementsbasedonstate-of-artscienceandtechnologyasapplicabletovariousconsiderationsthathavebeenidentifiedasimportanttoensurereasonablesafetyandefficacyasitrelatestothebiocompatibilityandthemechanicalintegrityofthedevicecomponentsinsofttissueexpanderdevices.Thisspecificationisnotintendedtolimitthescienceandtechnologythatmaybeconsideredandappliedtoensureperformancecharacteristicsofsubjectdeviceinintendedapplications.Whennewinformationbecomesavailableorchangesinstate-of-artscienceandtechnologyoccurandrelevancetosubjectdeviceshasbeenestablishedbyvalidscience,itisintendedthatthisspecificationwillberevisedinaccordancewithASTMguidelines.1.1Thisspecificationcoverstherequirementsforsingleusesalineinflatable,smoothandtexturedtissueexpansiondevicestobeusedintraoperativelyorimplantedfortypicallylessthan6monthsandthenremoved.1.2Limitations:1.2.1Thisspecificationappliesonlytosoft-tissueexpanderdevicesfabricatedwithelastomershells.Itdoesnotnecessarilycoveranycustomfabricatedsofttissueexpanderdevicemanufacturedtoanyotherspecification.1.2.2Thisspecificationapplies,inpart,tocombinationx201C;expander/mammaryx201D;devicesasclassifiedinSection4.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard,valuesinparenthesesareforinformationonly.1.4Thefollowingstatementpertainsonlytothetestmethodsandrequirementsportion,Section9,ofthisspecification.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:85_100
【页数】:5P.;A4
【正文语种】:英语
【原文标准名称】:人体软组织扩张器具的标准规范
【标准号】:ASTMF1441-2003(2009)
【标准状态】:现行
【国别】:美国
【发布日期】:2003
【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】:F04.32
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:elastomer;expander;implant;implantmaterial;medicaldevice;plasticsurgery;softtissueexpander;Expanderdevices;Orthopaedicmedicaldevices--specifications;Softtissueimplantmaterials
【摘要】:Thisspecificationcontainsrequirementsbasedonstate-of-artscienceandtechnologyasapplicabletovariousconsiderationsthathavebeenidentifiedasimportanttoensurereasonablesafetyandefficacyasitrelatestothebiocompatibilityandthemechanicalintegrityofthedevicecomponentsinsofttissueexpanderdevices.Thisspecificationisnotintendedtolimitthescienceandtechnologythatmaybeconsideredandappliedtoensureperformancecharacteristicsofsubjectdeviceinintendedapplications.Whennewinformationbecomesavailableorchangesinstate-of-artscienceandtechnologyoccurandrelevancetosubjectdeviceshasbeenestablishedbyvalidscience,itisintendedthatthisspecificationwillberevisedinaccordancewithASTMguidelines.1.1Thisspecificationcoverstherequirementsforsingleusesalineinflatable,smoothandtexturedtissueexpansiondevicestobeusedintraoperativelyorimplantedfortypicallylessthan6monthsandthenremoved.1.2Limitations:1.2.1Thisspecificationappliesonlytosoft-tissueexpanderdevicesfabricatedwithelastomershells.Itdoesnotnecessarilycoveranycustomfabricatedsofttissueexpanderdevicemanufacturedtoanyotherspecification.1.2.2Thisspecificationapplies,inpart,tocombinationx201C;expander/mammaryx201D;devicesasclassifiedinSection4.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard,valuesinparenthesesareforinformationonly.1.4Thefollowingstatementpertainsonlytothetestmethodsandrequirementsportion,Section9,ofthisspecification.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:85_100
【页数】:5P.;A4
【正文语种】:英语
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