【英文标准名称】:StandardPerformanceSpecificationforFoleyCatheter
【原文标准名称】:弗利医用导管的性能规范
【标准号】:ASTMF623-1999(2006)
【标准状态】:现行
【国别】:
【发布日期】:1999
【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】:F04.34
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:医疗设备;医学科学;医用导管;性能
【英文主题词】:ballooncatheter;bladderdrainage;urology
【摘要】:1.1Thisperformancespecificationestablishesperformancerequirementsfortheshort-termutilizationofasingle-use,balloon-retentioncatheter,Frenchsizes12through26inclusive,usedbythemedicalprofessionsforprovidingameansofbladderdrainagebymeansoftheurethra.Theproductismanufacturedinvarioussizesandmaterialssuchaslatex,silicone,rubber,andvariouspolymers(aswellascombinationsofthese)andisprovidednonsterileforsterilizationandsterileforsingleuseonly.Catheterswhosesurfacehasbeenchemicallytreatedtoeffectbiocompatibilityormicrobialpropertiesmaybetestedtothisspecification.1.2ExclusionsLong-termindwellingusage(over30days)isencounteredwiththisproduct,butnotcommonly,andisthereforeconsideredanexceptiontothisspecification.Similarly,theuseofsuchcathetersfornonurethralcatheterization(suchasfornephrostomy,suprapubiccystostomy,ureterostomy,gastrostomy,enemas,andsoforth)isexcludedfromthescopeofthisspecification.Likewise,threelumencatheters,30-cm3balloonandpediatriccatheters,andcatheterswhosesurfacehasbeenchemicallytreatedtoenhancetheirlubricityhavenotbeentestedtothisspecificationandexcludedfromthescopeofthisspecificationandwillrequireseparatestandarddevelopment.Thisstandardmayinvolvehazardousmaterials,operations,andequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcernsassociatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C48
【国际标准分类号】:11_040_20
【页数】:8P.;A4
【正文语种】: