For filter manufacturers, the superior performance of their products needs to be recognized by the market, and the “universal language” of this recognition is internationally recognized certification. Making an informed choice among different systems, such as European EN 1822, international ISO 29463, and North American IEST standards, directly impacts a company’s market access, brand positioning, and business success.
Three Mainstream International Certifications:
1. European Standard (EN 1822)
EN 1822 is one of the most influential standards, revolutionary in its introduction of the “Most Penetrating Particle Size” (MPPS) concept. It posits that filter efficiency for different particle sizes is not linear; MPPS represents the lowest efficiency point, and efficiency at this particle size represents the filter’s “minimum performance guarantee.” EN 1822 classifies filters into EPA (E10-E12), HEPA (H13-H14), and ULPA (U15-U17) grades. This standard is renowned for its rigorous theoretical framework and is the cornerstone of European market access, particularly favored by the pharmaceutical and high-end manufacturing industries.
2. International Standard (ISO 29463)
ISO 29463 aims to reconcile the differences between European and American standards. Rooted in EN 1822, it also employs the MPPS method but with a more detailed classification. It further subdivides the H13-H14 and U15-U17 grades in EN 1822 into more levels, such as ISO 35 H to ISO 75 U. A key difference is that the same filter might be rated H14 (HEPA) under the EN standard, but under the ISO standard, due to its higher efficiency, it might be classified as ISO 50 U (ULPA). The ISO standard is increasingly becoming the preferred choice for global markets, especially emerging markets, and companies seeking international recognition.
North American Standards (IEST-RP-CC001 / MIL-STD-282)
The North American system has a long history and typically uses a fixed particle size of 0.3 microns (for HEPA) or 0.1-0.2 microns (for ULPA) as the test particle size. Its classic testing method is DOP/PAO aerosol scanning leak detection. This system is deeply rooted in the US defense, aerospace, and traditional industrial sectors and is a must-know rule for entering the North American market.
How to Choose a Certification System?
For filter manufacturers, choosing the right certification system requires a comprehensive weighing of technical, market, and cost factors. Based on years of experience, Trenntech, a filtration solutions provider from Frankfurt, offers the following advice:
Economical Certification Combination:For filters used in commercial buildings, it is recommended to choose ISO 29463 basic certification (efficiency + resistance) + UL 900 fire resistance certification. This combination certification costs approximately €8,000-€12,000, with a testing cycle of 4-6 weeks, but it grants the product access to major North American and European markets.
Professional-Grade Certification System: Medical and laboratory filters require full ISO 29463 certification (including MPPS efficiency, dust holding capacity, and sealing) +EN 12469 biosafety cabinet compatibility certification + specific pathogen filtration efficiency verification. The total cost is approximately €25,000-€35,000, with a cycle of 8-12 weeks, but this is a prerequisite for entering the global high-end medical market.
Flagship-Grade Certification Solution:Semiconductor and aerospace-grade products require ISO 29463 certification +IEST-RP-CC034 cleanroom compatibility testing + ESTEC space environment verification (if applicable). The total investment may exceed €50,000, with a testing cycle of up to 6 months, but the resulting product premium can reach 200-300%.
When choosing a certification system for HEPA/ULPA filters, EN 1822, ISO 29463, and the North American IEST standard are no longer a single choice, but rather a “menu” that can be selected based on different product lines and market strategies. Successful players know how to flexibly use these “international languages” to transform cold test reports into a cornerstone of global customer trust, ultimately allowing the light of high-efficiency filtration technology to penetrate the barriers of standards and illuminate every corner that needs clean air.