解析室IQOQ.docVIP

IQ and OQ of Aeration Room of ETO Department 解析室的安装鉴定和操作鉴定 TABLE OF CONTENTS Purpose ………………………………………………………. …………………………..3 Scope …………………………………………………………….. ……………………….3 Specifications ……………………………………………………. ………3 References………………………………………………………….………………3 Responsibilities……………………………………………………………………………..4 Procedure……………………………………………………………………………5 Summary of Acceptance Criteria………………………………………………………….7 Certification of Qualification…………………………7 Subsequent Validation…………………………………………………………………..…7 List of Attachments 附件清单 Attachment 1: Air flow direction trend………………………………………………………8 附件1：气体流向趋势图 Attachment 2: Temperature sensors placement of operational qualification……………9 附件2：操作鉴定时温度传感器放置图 目的Purpose 1.1 The purpose of IQ and OQ is to demonstrate that the aeration room temperature and air flow rate meet specification, air flow patterns will be determined, all will be done in accordance with ANSI/AAMI/ISO11135-1994, Page.12: A3.3 Aeration. 安装鉴定和操作鉴定目的是为了证明解析室的温度和气体流速满足规格，确定气流模式，所有将根据ANSI/AAMI/ISO11135-1994，第12页，A3.3解析来执行。 范围Scope 2.1 This protocol applies to the aeration room IQ and OQ of ETO department. 该方案适用于ETO车间的解析室的安装鉴定及操作鉴定。 2.2 During the sterilization process, use EO mixture gas: EO/CO2: 40/60 在灭菌过程中，使用环氧乙烷混合气体：EO/CO2：40/60 说明Specifications 3.1 Temperature range of aeration room: 34—50℃ 解析室的温度范围：34-50℃ 3.2解析室尺寸Aeration room dimensions: Aeration room: 500cm×330cm×190cm 解析室：500cm×330cm×190cm 3.3 Temperature sensor: JR-1000 温度传感器. JR-1000 Temperature sensor of aeration room: WZP2-231 解析室的温度传感器：WZP2-231 4. 相关文件References 3.1 ANSI/AAMI ISO 11135:1994, Industrial ethylene oxide sterilization –  Validation and routine control ANSI/AAMI ISO 11135:1994，工业环氧乙烷灭菌--验证和常规控制 3.2 EN 550: 1994, Sterilization of medical devices – Validation and routine  control of ethylene oxide sterilization EN 550: 1994，医疗器械灭菌--环氧乙烷灭菌验证和常规控制 5. 职责Responsibilities: All personnel involved with the execution of this protocol will be trained to the require