手机出厂日期：2009.8 22 目的和范围本次验证是此台灭菌设备的例

Phone Release date: 2009.8 2 <br>A second object and scope <br>of this verification is a routine annual verification of this stage sterilization equipment, through the performance parameters ability to execute various components of the equipment, the maintenance situation of routine maintenance, the operator of the situation, the key instrument metering and usage, demonstrate the ability of this verification ethylene oxide sterilizer equipment operation within the operating parameters and the ability to operate under extreme operating specification process comprises, according to the conventional devices can ensure sterilization vanishing bacteria sterilization parameters for sterilizing objects. <br>References 3 <br>3.1 "Manual sterilizer" <br>3.2 "and QP6 / infrastructure management program 02" <br>3.5 of "EN 1422 medical sterilizer. Ethylene oxide sterilizer. Requirements and test methods" <br>3.7 "GB 18279.2-2015 the AT sterilization of health care products - ethylene oxide - part 2: GB 18279.1 application Guide " <br>4 composition and functional verification team

Mobile phone factory date: 2009.8 2<br>2 Purpose and scope<br>This verification is the routine annual verification of this sterilization equipment, through the performance of the various components of the equipment, parameter stoush, daily maintenance, operator situation, key instrument measurement and use, proof of this verification of the ability of the ethylene oxide sterilizing cabinet equipment to operate within the operating parameters of the operating parameters, to ensure that sterilization equipment can be in accordance with the existing parameters of sterilization.<br>3 Reference file<br>3.1 "Sterilizer Instructions"<br>3.2 QP6/02 Infrastructure Management Procedure<br>3.5 EN 1422 Medical Sterilization Cabinets . . . ethylene oxide sterilization cabinets . . . requirements and test methods<br>3.7 "GB AT 18279.2-2015 Sterilization ethylene oxide for healthcare products Part 2: GB 18279.1 Application Guide"<br>4 Verification team composition and duties

Mobile phone factory date: August 2, 2009<br>2 purpose and scope<br>This verification is a routine annual verification of this sterilization equipment. Through the performance of each part of the equipment, the ability to execute parameters, the situation of daily maintenance, the situation of operators, the measurement and use of key instruments, it is proved that the equipment of ethylene oxide sterilization cabinet in this verification can operate within the range of operating parameters and under the operating limit including process specifications To ensure that the sterilization equipment can sterilize the sterilized articles according to the existing sterilization parameters.<br>3 references<br>3.1 sterilizer operation manual<br>3.2 qp6 / 02 infrastructure management procedure<br>3.5 en 1422 medical sterilization cabinets - ethylene oxide sterilization cabinets - Requirements and test methods<br>3.7 GB at 18279.2-2015 sterilization of medical and health care products ethylene oxide Part 2: Application guide of GB 18279.1<br>4. Composition and position of validation team<br>