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ISO 29463-2:2011 provides the essential specifications for aerosol production, measuring equipment, and particle-counting statistics used in testing high-efficiency filters. This part is the technical foundation for the entire ISO 29463 series, defining the aerosol generation methods, particle measurement devices, and statistical procedures that ensure reliable and reproducible filter test results.
| Equipment Type | Application | Particle Size Range |
|---|---|---|
| Optical Particle Counter (OPC) | Upstream/downstream particle counting | 0.3-10 um |
| Condensation Particle Counter (CPC) | Ultra-fine particle detection | 0.01-3 um |
| Differential Mobility Analyzer (DMA) | MPPS determination | 0.01-1 um |
| Aerosol Photometer | Mass-based penetration measurement | 0.1-2 um |
| Dilution System | High concentration sample conditioning | All sizes |
The standard specifies both mono-disperse and poly-disperse aerosol generation methods. Mono-disperse aerosols, produced using electrospray or vibrating orifice generators, provide precise particle size selection for MPPS determination. Poly-disperse aerosols, generated using pneumatic or ultrasonic nebulizers, offer higher concentrations for overall efficiency testing across a broad size range.
Aerosol substances specified include DEHS (di-ethyl-hexyl-sebacate), DOP (di-octyl-phthalate), paraffin oil, NaCl, and KCl. The choice between liquid and solid aerosols affects particle counting methodology and may influence measured efficiency values for certain filter media types.
Selecting the appropriate particle counter for HEPA/ULPA testing requires understanding the counter’s sizing accuracy, counting efficiency, and coincidence error characteristics. Optical particle counters require careful calibration with certified reference particles (PSL spheres) and regular maintenance to maintain accuracy.
The standard provides detailed specifications for particle counting statistics, including counting uncertainty calculations based on Poisson statistics. For high-efficiency filters, counting times must be sufficiently long to accumulate statistically significant particle counts downstream of the filter.
Dilution systems are essential when testing filters with high upstream concentrations. The standard specifies dilution ratios and verification procedures to ensure diluters do not introduce measurement artifacts. Isothermal dilution is preferred to avoid particle growth or shrinkage due to temperature changes.
The standard requires that particle counters used for HEPA/ULPA testing be calibrated using certified monodisperse polystyrene latex (PSL) spheres traceable to national metrology institutes. The calibration must verify both the particle sizing accuracy (typically within +/- 5% of the certified size) and the counting efficiency at each size channel. For optical particle counters, the calibration covers the range of 0.3-10 um, while CPCs require calibration verification at their minimum detectable particle size.
Daily verification checks using a reference aerosol source are mandatory to detect any drift in instrument performance between calibrations. The standard recommends maintaining control charts of key calibration parameters including particle size calibration offsets, counting efficiency, and flow rate to enable early detection of instrument degradation.
The standard provides detailed maintenance and inspection intervals for all test equipment. Optical particle counters require regular cleaning of optics, verification of flow rate accuracy, and scheduled replacement of laser diodes and detection electronics. Condensation particle counters require maintenance of the saturator and condenser sections to ensure consistent droplet growth conditions. The standard recommends establishing instrument-specific maintenance schedules based on usage intensity and manufacturer recommendations, with all maintenance activities documented in instrument logbooks.
Quality assurance procedures include regular participation in inter-laboratory comparison programs, verification of instrument calibration using independent reference methods, and establishment of statistical process control limits for routine measurements. The standard emphasizes that the reliability of HEPA/ULPA filter classification depends fundamentally on the quality of the measurement instrumentation, and inadequate instrument maintenance is one of the most common causes of erroneous filter classifications in practice.
The differential mobility analyzer specified in ISO 29463-2 is used for precise particle size classification in the submicron range, essential for MPPS determination. The DMA classifies particles based on their electrical mobility in an applied electric field, selecting particles of a specific size for downstream detection. When used with a CPC as the detector, the DMA-CPC system provides the most accurate method for determining the efficiency of filter media as a function of particle size in the MPPS region. The standard specifies requirements for the DMA including sheath flow rate control within +/- 2%, voltage stability within +/- 0.5%, and temperature control to avoid classification errors due to gas property variations. The aerosol photometer, which measures the light scattered by particles in a cloud, provides a simpler and faster measurement method suitable for routine testing and production quality control. However, the photometer does not provide particle size information and cannot be used for MPPS determination. The standard specifies the conditions under which photometer measurements are acceptable and the required correlation with reference particle counting methods.