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【英文标准名称】:StandardSpecificationforImplantableBreastProstheses
【原文标准名称】:可植入假乳房标准规范
【标准号】:ASTMF703-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:外科植入物;医疗设备;医学科学;修复装置
【英文主题词】:breastprosthesis;gel-salineprosthesis;implant;salineinflatableprosthesis;siliconeelastomer;siliconegelprosthesis;softtissueimplant
【摘要】:1.1Thisspecificationcoverstherequirementsforsiliconegel-filledandsaline-inflatablesiliconegel-filledimplantablebreastprosthesesintendedforuseinsurgicalreconstruction,augmentation,orreplacementofthebreast.1.2Limitations8212;Thisspecificationdoesnotcovercustomfabricatedimplantablebreastprostheses.1.3Single-usesaline-inflatable,smooth,andtexturedsiliconeshellimplantablebreastprosthesesareaddressedinSpecificationF2051.1.4ThevaluesstatedinSIunitsaretoberegardedasthestandard.Theinch-poundunitsgiveninparenthesesareforinformationonly.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:10P.;A4
【正文语种】: