一.什么是隔离器
A decontaminated unit, supplied with Class 100 (ISO 5) or heigher air quality, that provieds uncompromised, continous isolation of it intrerior from the external environment. (e.g. Surrounding cleanroom air and personal)
翻译：
提供100级（ISO 5）或更高空气质量净化单元，其内部环境与外部环境保持持续的隔离以及无干扰。（例如洁净室内空气和人员）
二.法规对隔离测试设备的要求
• C.12 离析试验
• Light-scattering airborne-particle counter, see C.5.1.
• 光散射空气粒子计数器，见 C.5.1
Light-scattering airborne-particle counter (LSAPC), capable of counting and sizing single airborne particles and reporting size data in terms of equivalent optical diameter. Refer to ISO 14644-1.
光散射空气粒子计数器，能够对单个空气粒子进行计数和测量，并根据等效光学直径报告尺寸数据。参考ISO 14644-1。
• Aerosol generator, see C.5.2.
• 气溶胶发生器，见 C.5.2
Aerosol generator, capable of generating particles within the size range 0.1 μm-1.0 μm at a constant concentration, which may be generated by thermal, hydraulic, pneumatic, acoustic, chemical or electrostatic method.
气溶胶发生器，能够以恒定浓度产生 0.1μm-1.0μm尺寸范围内的颗粒，可通过热、液压、气动、声学、化学或静电方法产生。
• Aerosol source substances, see C.5.3.
• 气溶胶源物质，见 C.5.3
Test aerosol source substances.Typically, the following substances are used to generate test aerosols, liquid or solid test aerosol for generating by spraying or atomizing into the atmosphere:
测试气溶胶源物质。典型地，以下物质用于产生测试气溶胶，液体或固体测试气溶胶，用于通过喷射或雾化到大气中而产生:
a）poly-alpha olefin (PAO) oil, 4 centistokes PAO; 聚 α-烯烃(PAO)油，4 厘沲 PAO；
b）dioctyl sebacate (DOS);癸二酸二辛酯；
c）di-2-ethyl hexyl sebacate (DEHS); 癸二酸二-2-乙基己酯(DEHS)；
d）dioctyl (2-ethyl hexyl) phthalate (DOP1);邻苯二甲酸二辛酯(2-乙基己基)(DOP1)
e）food quality mineral oil; 食品质量矿物油(如化学文摘社编号 8042-47-5)；
f）paraffin oil; 石蜡油；
g）microspheres with an appropriate diameter.具有适当直径的微球。
If the required concentration can be achieved, atmospheric aerosol may also be used.
如果能够达到要求的浓度，也可以使用大气气溶胶。
• Dilution system, see C.5.4.
• 稀释系统，见 C.5.4
Dilution system, equipment, in which the aerosol is mixed with clean air in a known volumetric ratio to reduce concentration.
稀释系统、设备，其中气溶胶与清洁空气以已知的体积比混合，以降低浓度。
三、检测方法
As a minimum, testing should be carried out:
至少应进行测试:
a）in connection with classification according to ISO 14644-1;根据ISO 14644-1 进行分类；
b）at verification during start-up; 启动期间的验证；
c）at verification after failures have been identified and rectified；在确认和纠正故障后进行验证；
d）at verification after modification; 修改后的验证；
e）during periodic testing. 定期测试期间。
A risk assessment should be performed to establish the appropriate intervals for periodic testing.应进行风险评估，以建立定期测试的适当间隔。
Monitoring data, trend and test result should be used to confirm and, if appropriate, adjust time intervals for the selected tests.应使用监控数据、趋势和测试结果来确认并调整所选测试的时间间隔(如果合适)。