原文在这里:Cleanroom Qualification is the overall process of assessing the level of compliance of a classified cleanroom or clean air equipment with its intended use. As part of the qualification requirements of Annex 15, the qualification of cleanrooms and clean air equipment should include (where relevant to the design/operation of the installation):
洁净室鉴定是评估A级洁净室或洁净空气设备与其预期用途相符程度的整个过程。作为附件15资格要求的一部分,洁净室和洁净空气设备的资格鉴定应包括(与安装的设计/操作有关的地方):
4.27.1. Installed filter leakage and integrity testing.
已安装的过滤器的泄漏和完整性测试。
4.27.2. Airflow measurement Volume and velocity.
空气流量、体积和速度测量。
4.27.3. Air pressure difference measurement.
气压差测量
4.27.4. Airflow direction and visualisation.
气流方向和可视化。
4.27.5. Microbial airborne and surface contamination.
空气中的微生物和表面污染。
4.27.6. Temperature measurement.
温度测量。
4.27.7. Relative humidity measurement.
相对湿度测量。
4.27.8. Recovery testing.
自净测试。
4.27.9. Containment leak testing.
密闭性泄漏测试。。