设备描述如下：设备编号：TMSCBGA09-31设备型号：UNQ-EN

Apparatus is described as follows: <br>Device ID: TMSCBGA09-31 <br>equipment Model: UNQ-EN-15 <br>sterilizer lumen size: 6750mm * 1350mm * 1700mm <br>available volume: 16m3 <br>Pressure range: -80 ~ + 80kPa <br>manufacturing number: 09-15-1 (CE) <br>maximum power: 54kw <br>power supply voltage: 380v <br>frequency: 50Hz <br>arranged sensors: a temperature sensor 5, a humidity sensor, a pressure transmitter (see the details in Appendix meter) <br>Release date: 2009.8 2 <br>second object and the scope of <br>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 of routine maintenance situation, the situation of operators, metering and usage of key instruments to prove this proficiency ethylene oxide sterilizer equipment operating within the operating parameters and the ability to operate under extreme operating specification process comprising ensure sterilization apparatus capable of sterilizing articles in accordance with conventional sterilization sterilization parameters . <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

The device is described as follows:<br>Device number: TMSCBGA09-31<br>Device Model: UNQ-EN-15<br>The cavity size of the sterilizer: 6750mm x 1350mm x 1700mm<br>Available volume: 16m3<br>Pressure range: -80 to 80kPa<br>Manufacturing Number: 09-15-1 (CE)<br>Maximum power: 54kw<br>Supply voltage: 380v<br>Frequency: 50Hz<br>Configuration sensor: 5 temperature sensors, 1 humidity sensor, 1 pressure transmitter (see appendix for meter details)<br>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

The equipment is described as follows:<br>Equipment No.: tmscbga09-31<br>Equipment model: unq-en-15<br>Chamber size of sterilizer: 6750mm * 1350mm * 1700mm<br>Available volume: 16m3<br>Pressure range: - 80 ~ + 80kPa<br>Manufacturing No.: 09-15-1 (CE)<br>Maximum power: 54kw<br>Power supply voltage: 380V<br>Frequency: 50Hz<br>Configuration sensor: 5 temperature sensors, 1 humidity sensor and 1 pressure transmitter (see Appendix for details of in-service instrument)<br>Ex 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>