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免费下载 | 医疗器械设备确认IQ,OQ和PQ模版

  • 2026-07-31 03:02:23
免费下载 | 医疗器械设备确认IQ,OQ和PQ模版

医疗器械设备确认文件（IQ-OQ-PQ）

文件编号：

设备名称：

型号 / 规格：

安装地点：

版本号：V1.0

一、安装确认（IQ）

检查项目
检查内容
检查结果（是 / 否 / NA）
备注 / 支持文件编号
1. 设备外观与安装位置
设备外观无损伤，安装位置符合布局图、环境要求（温湿度、洁净度等）
2. 公用系统连接
电源、压缩空气、冷却水等连接正确，压力 / 流量符合设备要求
3. 计量与校准
设备自带仪表、传感器已完成计量校准，证书在有效期内
4. 安全防护装置
急停、报警、防护门等安全功能正常可用
5. 技术文件完整性
设备说明书、电路图、操作手册、合格证等文件齐全归档
6. 软件安装（如适用）
设备控制软件已正确安装，版本与要求一致

IQ 结论：设备已按设计要求完成安装，所有检查项均符合规定，IQ 通过。

确认人：

日期：

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  1. CONNECT:[ UseTime:0.000694s ] mysql:host=127.0.0.1;port=3306;dbname=no_yeyulingfeng;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.000930s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000382s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000315s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.000686s ]
  6. SELECT * FROM `set` [ RunTime:0.000263s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.000730s ]
  8. SELECT * FROM `article` WHERE `id` = 487113 LIMIT 1 [ RunTime:0.000521s ]
  9. UPDATE `article` SET `lasttime` = 1785442631 WHERE `id` = 487113 [ RunTime:0.013524s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 66 LIMIT 1 [ RunTime:0.000310s ]
  11. SELECT * FROM `article` WHERE `id` < 487113 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000549s ]
  12. SELECT * FROM `article` WHERE `id` > 487113 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.000416s ]
  13. SELECT * FROM `article` WHERE `id` < 487113 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.004567s ]
  14. SELECT * FROM `article` WHERE `id` < 487113 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.000736s ]
  15. SELECT * FROM `article` WHERE `id` < 487113 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.000904s ]
0.096746s