纯蒸汽测试报告

The Quality of Pure Steam Testing Report

纯蒸汽质量

测试报告

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 (4)

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 (7)

8.DEVIATION LIST偏差清单 (7)

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。

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 2010

HTM 2010

➢BS EN285 2006

BS EN285 2006

➢KSA Steam Quality Test Kit SQ1 Operation Procedure :TSP-SOP-VTS-22 KSA蒸汽质量检测仪操作规程：TSP-SOP-VTS-22