Designation:F882–84(Reapproved2002)StandardPerformanceandSafetySpecificationforCryosurgicalMedicalInstruments1ThisstandardisissuedunderthefixeddesignationF882;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.ThisstandardhasbeenapprovedforusebyagenciesoftheDepartmentofDefense.INTRODUCTIONThisperformanceandsafetyspecificationwasdevelopedbyTaskForceF04.08onCryosurgicalMedicalInstruments.ThisspecificationisintendedtoprovidetheuserofCryosurgicalMedicalInstrumentswiththeassurancethattheequipmentwillmeetorexceedallsafetyandperformancelevelsestablishedbythisdocumentasclaimedbythemanufacturer.Thisispredicatedontherequirementsthattheequipmentisoperatedaccordingtothemanufacturer’srecommendations.Since,inthepursuitofimprovedhealthcareandreducedmedicalcosts,themedicalindustryisrequiredtobeinnovativeanddynamic,thisstandardmustbecapableofbeingupgradedinaswiftandefficientmanner.Allinquiriesregardingthisstandardshouldbeaddressedto:CommitteeF04StaffManager,ASTM,100BarrHarborDrive,WestConshohocken,PA19428.1.Scope1.1Thisspecificationcoversstandardsamanufacturershallmeetinthedesigning,manufacturing,testing,labeling,anddocumentingofcryosurgicalmedicalinstruments,butitisnottobeconstruedasproductionmethods,qualitycontroltech-niques,ormanufacturer’slotreleasecriteria,orclinicalrec-ommendations.1.2Thisspecificationrepresentsthebestcurrentlyavailabletestproceduresatthistimeandisaminimumsafetyandperformancestandard.1.3Thisspecificationcoversonlythosecryosurgicalde-vicesintendedforuseonhumansoranimalsfortherapeuticpurposes.Thisspecificationassumestheuseriswell-trainedintheproceduresofcryosurgeryandhastheabilitytodetermineifanabnormalityistreatablebycryosurgery,particularlybythetypeofequipmenttobeused.1.4Cryosurgicalmedicalinstrumentsproducelowtempera-tureseitherinsideacryoprobeordirect...
