中国GMP指南2023版规定，微生物限度检查应在不低于D 级背景下的生物安全柜或超净工作台中进行。

美国药典规定：For less-critical microbiological testing, such as with nonsterile product or intermediate bioburden samples, testing under a unidirectional airflow (UDAF) cabinet, or as applicable is preferable. During qualification, the UDAF air must meet the air quality grade for which it is being qualified. In addition to the qualification, the cabinet’s environment (air and surfaces) may be tested periodically. The testing frequency and levels defined would depend on the microbiological grade of the product tested, the quality of air that can be delivered by the UDAF design and filters, the fact that nonsterile material may be present in the UDAF and the cleaning/disinfection regime. 我理解为，微生物限度检查应在单向气流柜中进行检测，该单项气流柜的空气洁净度应不低于待测样品的生产环境。

EU GMP 无菌附录1中说，A级环境应持续监控悬浮粒子。

问题：

1. 欧盟是否有微生物限度检测环境的要求呢？

2. 生物安全柜或洁净工作台是否需要规定洁净度等级，比如A级/A级送风？如果定义为A级，按EU GMP无菌附录1，每次进行微生物限度检测时，需要持续监控悬浮粒子吗？