Rev.:A Sterilization Equipment:HDX-1 Sterilization Cabinet (1m3)
灭菌设备：HDX-1灭菌柜（1立方米）柳州旅游景点大全
Product: XXXXX
产品：XXXXX
NO. HY-ETO-KXS-699-02（A）
Ethylene Oxide Sterilization Validation Report
环氧乙烷灭菌验证报告
Product Name: XXXXXXX出纳员主要负责什么工作
产品名称：XXXX
Qualification Method: Half-cycle Method
确认方法：半周期法
Sterilization of Health Care Products - Ethylene Oxide - Part 1: Requirements for Development, V alidation and Routine Control of a Sterilization Process for Medical Devices (EN ISO 11135-1: 2014) ISO11135-1：2007《医疗器械- 环氧乙烷- 灭菌确认和常规控制》
编制人Prepared by：日期Date：
审核Reviewed by：日期Date：
批准Approved by：日期Date：
[Sterilizer A]
目录Contents
A.Preface
一、序言
B. Abstract
二、摘要
C. Company Profile
三、公司介绍
D. Product (Sterilization Load) Description
四、产品（灭菌负载）说明
E. Sterilization Validation Plan and Contents
五、灭菌验证的方案及容
I. Installation Qualification of Sterilization Equipment
1. 灭菌设备的安装确认
II. Physical Performance Validation of Sterilization Equipment
2. 灭菌设备物理性能验证
(a) Equipment specification, model and description
①设备的规格、型号及说明(a)
(b) Measurement condition of instruments and probes on equipment
②设备上仪表、探头的计量状况(b)
(c) Equipment daily maintenance & repair and records血红蛋白偏高
③设备日常的维护和保养及记录怎样煮大块牛肉
(d) Specific contents of equipment physical performance validation
④设备物理性能验证的具体内容
III. Initial or Desired Sterilization Parameters (Including Concentration) 3. 初定或希望确定的灭菌参数（包括浓度）
IV. Initial or Desired Sterilization Process
4. 初定或希望确定的灭菌过程
V. Test Run of Equipment Simulated Sterilization Process
5. 设备模拟灭菌过程的试运行
电脑总蓝屏
VI. Validation of Product (Load) Sterilization Effect
6. 产品（负载）灭菌效果验证
(a) Selection and storage of EO gas
① EO气体的选用和存储
(b) Selection of humidification water
②加湿用水的选用
(c) Test of Product Initial Contaminating Bacteria
③产品初始污染菌的检测
(d) Application of ethylene oxide sterilization chemical indicator.
④环氧乙烷灭菌化学指示片的应用
(e) Application of American 3M biological indicator
⑤美国3M生物指试剂的应用
(f) Regular test in company biological laboratory
⑥公司生物化验室的定期检测
(g) Regular test in municipal sanitation and anti-epidemic station.
⑦市卫生防疫站的定期检测
F. Short Cycle Sterilization
高中自评六、短周期灭菌
G. Performance Change of Product before and after Sterilization
七、灭菌前后产品性能的变化
H. EO Health Inspection in Sterilization Environment
八、灭菌环境中EO卫生检测
I. Test of EO Residues in Product
九、产品中EO残留量的检测
J. Conclusions
十、结论
手机内存
K. Appendixes
十一、附录
L. Data Saving
十二、资料保存
M. References
技校专业
十三、参考文献
Appendixes:
附录
Appendix: A17-01 Measurement Certificates for Equipment instruments and Meters 附件A17-01. 设备的仪器、仪表等计量证书
Appendix: A17-02 Biochemical Test Reports
附件A17-02. 生化检测报告
A.Test Reports for Product Initial Contaminating Bacteria
一、产品的初始污染菌检测报告
(Including: A17-02-1, A17-02-5, A17-02-9, A17-02-13, A17-02-17)
（包括：A17-02-1, A17-02-5, A17-02-9, A17-02-13, A17-02-17）
B.Test Reports of Biological Reagent (BI)
二、生物试剂（BI）的检测报告
(Including: A17-02-2, A17-02-6, A17-02-10, A17-02-14, A17-02-18)
（包括：A17-02-2, A17-02-6, A17-02-10, A17-02-14, A17-02-18）
C.Sterility Test Reports for Products in Company Biochemical Laboratory
三、公司生化室产品无菌检测报告
(Including: A17-02-3, A17-02-7, A17-02-11, A17-02-15, A17-02-19)
（包括：A17-02-3, A17-02-7, A17-02-11, A17-02-15, A17-02-19）
D.Test Reports of EO Residues in Product
四、产品EO残留量检测报告
(Including: A17-02-4, A17-02-8, A17-02-12, A17-02-16, A17-02-20)
（包括：A17-02-4, A17-02-8, A17-02-12, A17-02-16, A17-02-20）
Appendix: A17-03 Sterilization Records for the 1st Half Cycle
附件A17-03. 第一次半周期的灭菌记录
Appendix :A17-04 Sterilization Records for the 2nd Half Cycle
附件A17-04. 第二次半周期的灭菌记录
Appendix :A17-05 Sterilization Records for the 3rd Half Cycle 附件A17-05. 第三次半周期的灭菌记录
Appendix: A17-06 Full Cycle Sterilization Records
附件A17-06. 全周期的灭菌记录
Appendix: A17-07 Short Cycle Sterilization Record
附件A17-07. 短周期灭菌记录
