纯蒸汽测试报告.docx

Page页码1 of 7The Quality of Pure Steam Testing Report 纯蒸汽质量测试报告The Quality of Pure SteamTesting Report纯蒸汽质量测试报告Company/Title 公司/职务Name姓名Signature 签名Date日期Written by 起草Reviewed审核Approved 批准Index 目录Page页码2 of 7The Quality of Pure Steam Testing Report 纯蒸汽质量测试报告1. PURPOSE 目的 32. SCOPE 范围 33. SYSTEM DESCRIPTION 系统描述 34. RESPONSIBILITY 职责 45. REGULATION AND GUIDANCE 法规和指南 46. TEST RESULTS ANALYSIS 测试结果分析 57. TEST APPENDICES LIST 测试清单确认 78. DEVIATION LIST 偏差清单 7Page页码3 of 7The Quality of Pure Steam Testing Report 纯蒸汽质量测试报告1. Purpose 目的The purpose of this testing report is to demonstrate that the Pure Steam Generation and Distribution System of consistently produces Pure Steam that meets the requirements specified in the EN285.该报告用于证明 纯蒸汽制备和分配系统产生的纯蒸汽满足EN285相关规定和要求。

2. Scope 范围The test items included in this report are the test items for pure steam specified in EN285, non-condensable gas, degree of superheat and dryness.本测试项目为EN285中规定的纯蒸汽测试项目：不凝性气体、过热度、干度3. Test Items Description 测试项目描述Dryness-describes a quality of steam that has been superheated. As the dryness factor of steam increases, the suitability of the steam as a medium for moist-heat sterilization diminishes. Dry steam is said to be adiabatically (or thermally) insulated against heat transfer.蒸汽干度值：描述己过热的一定质量的蒸汽，随着蒸汽干燥值因子增加，作为湿热灭菌的蒸汽的适 用性减少。

干燥蒸汽以绝热(或热分解)的方式阻止热传递Superheated Steam-Steam whose heat, at any given pressure, is higher than that indicated for the vaporization curve of water.过热蒸汽：在任何压力下，蒸汽的热度高于水的蒸发曲线Non-condensable gases(NCGs)-are defined as gases which cannot be liquefied by compression under the range of conditions of temperature and pressure used during the sterilization process. Low levels of NCGs contained in steam supplied to sterilizers can markedly affect the performance of the sterilizer and the efficacy of the process, cause chamber overheating and lead to inconsistencies in the performance of air detectors and failure of the Bowie-Dick test. Major NCGs are atmospheric air and carbon dioxide.不凝性气体(NCGs)：在灭菌过程中，在一定温度和压力范围下，压缩后仍无法被液化的气体。

灭 菌蒸汽里少量的不凝性气体会对灭菌器和灭菌过程造成显著影响，造成腔体过热，空气探测器运作 的不稳定， Bowie-Dick 测试的失败不凝性气体主要是空气和二氧化碳Page页码4 of 7The Quality of Pure Steam Testing Report 纯蒸汽质量测试报告4. Responsibility 职责Austar responsibility 奥星的职责✓ Testing execution, data collection 测试的实施，数据的收集✓ Report compilation报告的编写Client responsibility 客户职责✓ Supervision of testing process, review and approval of this report. 负责验证过程监督、报告的审核与批准，确保按批准的方案执行✓ Assessment and handling of changes and deviations occur during this testing 负责对测试实施过程中出现的变更和偏差的评价和处理✓ Deviation report compilation 偏差报告的编写5. Regulation and Guidance 法规和指南> HTM 2010HTM 2010> BS EN285 2006BS EN285 2006> KSA Steam Quality Test Kit SQ1 Operatio n Procedure :TSP-SOP-VTS-22 KSA蒸汽质量检测仪操作规程：TSP-SOP-VTS-22Page页码5 of 7The Quality of Pure Steam Testing Report 纯蒸汽质量测试报告6. Test Results Analysis 测试结果分析The testing of the quality of Pure Steam form Pure Steam Generation and Distribution System has been implemented at 2012 /04/26.在 2012 年 04 月 26 日对纯蒸汽制备和分配系统产生的纯蒸汽的质量进行了测试。

Test No.测试编号Title 名称Dates of the Test测试日期6.1Calibrati on of In strume nts and test SOP 测试仪器校验和SOP2012年04月26日All the testi ng in strume nts are with their respective calibrati on certificates and the calibrati on certificates are with in the valid calibrati on period.所有测试仪器仪表均具有校验报告，且在有效期内SOP list for the Test ing.以下为本次测试所需的SOP列表1. KSA Steam Quality Test Kit SQ1 Operation Procedure1. KSA蒸汽质量检测仪操作规程The test is PASS测试结论为 合格Page页码6 of 7The Quality of Pure Steam Testing Report 纯蒸汽质量测试报告Test No.TitleDates of the Test测试编号名称测试日期6.2Pure Steam Quality Verificati on 纯蒸汽质量确认2012年04月26日The Pure Steam by the Pure Steam Gen erati on and Distributi on System can meet the specified quality requireme nts.纯蒸汽制备和分配系统能够持续供应符合规定质量要求的纯蒸汽。

Test测试Acceptance Criteria 验收标准Non-conden sate gas 不凝性气体<3.5%(V/V)Dryn ess干度20.90Super heat. 过热度<25CPure Steam Non-conden sate gas test meets the requireme nt. Testi ng photos see theAppendix D. 纯蒸汽不凝性气体测试符合要求Pure Steam Dryn ess test meets the requireme nt.纯蒸汽干度测试，符合要求Pure Steam Super heat test meets the requireme nt..纯蒸汽过热度测试，符合要求The test is 测试结论为PASS合格Page页码7 of 7The Quality of Pure Steam Testing Report 纯蒸汽质量测试报告7. Test Appendices List 测试清单确认Test No.测试编号Appendices No. 附件编号Title 名称Page页数6.1附件1仪器仪表校验报告26.1附件2KSA蒸汽质量检测仪器操作规程76.2附件3不凝性气体测试记录26.2附件4过热值测试记录26.2附件5蒸汽干燥值测试记录28. Deviation List 偏差清单No deviation has been detected during the execution of the tests. 在进行测试时未检测到任何偏差。

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