純蒸汽測試報告

Page頁碼PAGE3ofNUMPAGES7TheQualityofPureSteamTestingReport純蒸汽質(zhì)量測試報告TheQualityofPureSteamTestingReport純蒸汽質(zhì)量測試報告Company/Title公司/職務(wù)Name姓名Signature簽名Date日期Writtenby起草Reviewed審核Approved批準(zhǔn)Index目錄1. Purpose目的 32. Scope范圍 33. SystemDescription系統(tǒng)描述 34. Responsibility職責(zé) 45. RegulationandGuidance法規(guī)和指南 46. TestResultsAnalysis測試結(jié)果分析 57. TestAppendicesList測試清單確認(rèn) 78. DeviationList偏差清單 7

Purpose目的ThepurposeofthistestingreportistodemonstratethatthePureSteamGenerationandDistributionSystemofconsistentlyproducesPureSteamthatmeetstherequirementsspecifiedintheEN285.

該報告用于證明純蒸汽制備和分配系統(tǒng)產(chǎn)生的純蒸汽滿足EN285相關(guān)規(guī)定和要求。Scope范圍ThetestitemsincludedinthisreportarethetestitemsforpuresteamspecifiedinEN285,non-condensablegas,degreeofsuperheatanddryness.本測試項目為EN285中規(guī)定的純蒸汽測試項目：不凝性氣體、過熱度、干度。TestItemsDescription測試項目描述Dryness-describesaqualityofsteamthathasbeensuperheated.Asthedrynessfactorofsteamincreases,thesuitabilityofthesteamasamediumformoist-heatsterilizationdiminishes.Drysteamissaidtobeadiabatically(orthermally)insulatedagainstheattransfer.蒸汽干度值：描述己過熱的一定質(zhì)量的蒸汽，隨著蒸汽干燥值因子增加，作為濕熱滅菌的蒸汽的適用性減少。干燥蒸汽以絕熱（或熱分解）的方式阻止熱傳遞。SuperheatedSteam-Steamwhoseheat,atanygivenpressure,ishigherthanthatindicatedforthevaporizationcurveofwater.

過熱蒸汽：在任何壓力下，蒸汽的熱度高于水的蒸發(fā)曲線。Non-condensablegases(NCGs)-aredefinedasgaseswhichcannotbeliquefiedbycompressionundertherangeofconditionsoftemperatureandpressureusedduringthesterilizationprocess.LowlevelsofNCGscontainedinsteamsuppliedtosterilizerscanmarkedlyaffecttheperformanceofthesterilizerandtheefficacyoftheprocess,causechamberoverheatingandleadtoinconsistenciesintheperformanceofairdetectorsandfailureoftheBowie-Dicktest.MajorNCGsareatmosphericairandcarbondioxide.

不凝性氣體（NCGs）：在滅菌過程中，在一定溫度和壓力范圍下，壓縮后仍無法被液化的氣體。滅菌蒸汽里少量的不凝性氣體會對滅菌器和滅菌過程造成顯著影響，造成腔體過熱，空氣探測器運作的不穩(wěn)定，Bowie-Dick測試的失敗。不凝性氣體主要是空氣和二氧化碳。Responsibility職責(zé)Austarresponsibility奧星的職責(zé)Testingexecution,datacollection

測試的實施，數(shù)據(jù)的收集Reportcompilation

報告的編寫Clientresponsibility客戶職責(zé)Supervisionoftestingprocess,reviewandapprovalofthisreport.

負(fù)責(zé)驗證過程監(jiān)督、報告的審核與批準(zhǔn)，確保按批準(zhǔn)的方案執(zhí)行。Assessmentandhandlingofchangesanddeviationsoccurduringthistesting

負(fù)責(zé)對測試實施過程中出現(xiàn)的變更和偏差的評價和處理。Deviationreportcompilation

偏差報告的編寫RegulationandGuidance法規(guī)和指南HTM2010

HTM2010BSEN2852006

BSEN2852006KSASteamQualityTestKitSQ1OperationProcedure:TSP-SOP-VTS-22

KSA蒸汽質(zhì)量檢測儀操作規(guī)程：TSP-SOP-VTS-22

TestResultsAnalysis測試結(jié)果分析ThetestingofthequalityofPureSteamformPureSteamGenerationandDistributionSystemhasbeenimplementedat2012/04/26.

在2012年04月26日對純蒸汽制備和分配系統(tǒng)產(chǎn)生的純蒸汽的質(zhì)量進行了測試。TestNo.

測試編號Title名稱DatesoftheTest

測試日期6.1CalibrationofInstrumentsandtestSOP測試儀器校驗和SOP2012年04月26日Allthetestinginstrumentsarewiththeirrespectivecalibrationcertificatesandthecalibrationcertificatesarewithinthevalidcalibrationperiod.

所有測試儀器儀表均具有校驗報告，且在有效期內(nèi)。SOPlistfortheTesting.

以下為本次測試所需的SOP列表1.KSASteamQualityTestKitSQ1OperationProcedure1.KSA蒸汽質(zhì)量檢測儀操作規(guī)程Thetestis

測試結(jié)論為PASS合格

TestNo.

測試編號Title名稱DatesoftheTest

測試日期6.2PureSteamQualityVerification純蒸汽質(zhì)量確認(rèn)2012年04月26日ThePureSteambythePureSteamGenerationandDistributionSystemcanmeetthespecifiedqualityrequirements.

純蒸汽制備和分配系統(tǒng)能夠持續(xù)供應(yīng)符合規(guī)定質(zhì)量要求的純蒸汽。Test測試AcceptanceCriteria驗收標(biāo)準(zhǔn)Non-condensategas

不凝性氣體<3.5%(V/V)Dryness

干度≥0.90Superheat.

過熱度<25℃PureSteamNon-condensategastestmeetstherequirement.TestingphotosseetheAppendixD.純蒸汽不凝性氣體測試符合要求。PureSteamDrynesstestmeetstherequirement.純蒸汽干度測試，符合要求。PureSteamSuperheattestmeetstherequirement..純蒸汽過熱度測試，符合要求。Thetestis

測試結(jié)論為PASS合格

TestAppendicesList測試清單確認(rèn)TestNo.

測試編號AppendicesNo.

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