文件编号编制审核批准版本日期日期日期插管车间挤出机挤管过程确认方案序号版次修订内容修订人批准人1 / 18目录1 目的 ........................................................................................................... 32 范围 ........................................................................................................... 33 确认依据 .................................................................................................... 34 设备概述 .................................................................................................... 35 确认小组组成 ............................................................................................. 56 重新确认的条件.......................................................................................... 57 确认方案 .................................................................................................... 57.1 IQ 方案..................................................................................................... 67.2 OQ 方案................................................................................................... 87.3 PQ 方案 .................................................................................................. 112 / 181 目的通过实施挤出机的挤出过程确认，从而保证挤出机搬迁后能够持续稳定地生产出符合既定要求的产品。2 范围2.1 确认的产品: 见附录 12.2 设备：挤管设备与模具信息见附录 13 确认依据3.1 机器的操作说明书、工作原理和安装图纸；3.2 参考文件ISO 5361Anaesthetic and respiratory equipment-Tracheal tubes and connectors,IDT.YY0337.1-2002 气管插管-第 1 部分：常用型插管及接头ISO 5366-1 Anaesthetic and respiratory equipment-Tracheal tubes-Part 1:tubes and connectors for usein adults, IDT.YY 0338.1-2002 气管切开插管-第一部分：成人用插管及接头YY 0338.2-2002 气管切开插管-第二部分：小儿用气管切开插管EN ISO 8336Suction catheter for use in the respiratory tractYY 0339-2009 呼吸道用吸引导管过程确认...
