医疗器械产品完整的环氧乙烷灭菌验证报告模板(中英文版).docxVIP

Sterilization Equipment:HDX-1 Sterilization Cabinet (1m3) 灭菌设备： HDX-1灭菌柜（1立方米） Product: XXXXX 产品：XXXXX NO. HY-ETO-KXS-699-02（A） Rev.:A Ethylene Oxide Sterilization Validation Report 环氧乙烷灭菌验证报告 Product Name: XXXXXXX 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, Validation 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 　 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 ③ 设备日常的维护和保养及记录 (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 VI. Validation of Product (Load) Sterilization Effect 6. 产品（负载）灭菌效果验证 (a) Selection and storage