纯蒸汽测试报告概要1.docVIP

The Quality of Pure Steam Testing 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 1. Purpose目的 3 2. Scope范围 3 3. System Description 系统描述 3 4. Responsibility职责 5. Regulation and Guidance 法规和指南 4 6. Test Results Analysis 测试结果分析 5 7. Test Appendices List测试清单确认 8. Deviation List偏差清单 Purpose目的 The purpose of this is to demonstrate that the Pure Steam Generation and Distribution System of consistently produces Pure Steam that meets the requirements specified in the EN285.该用于证明纯分配系统相关规定和要求。 Scope范围 The test items included in this 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。 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。 Responsibility职责 Austar responsibility奥星的职责 execution, dat