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【英文标准名称】:StandardSpecificationforImplantableSalineFilledBreastProsthesis
【原文标准名称】:可植入的盐水填充的乳房假体标准规范
【标准号】:ASTMF2051-2000(2006)
【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】:F04.32
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:breastprosthesis;gelsalineprosthesis;implant;salineinflatableprosthesis;siliconeelastomer;softtissueimplant
【摘要】:1.1Thisspecificationcoverstherequirementsforsingleusesalineinflatable,smoothandtexturedsiliconeshellimplantablebreastprostheses,intendedforuseinsurgicalreconstruction,augmentation,orreplacementofthebreast.1.2Limitations1.2.1Thisspecificationdoesnotcovercustomfabricatedimplantablebreastprostheses.1.2.2Thisspecificationdoesnotcovergel/salinetypeimplants,whicharewithinthescopeofSpecificationF703.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:6P.;A4
【正文语种】: