Criteria Behind Biohazard Protective Clothing: EN 14126

Why should we pay attention for EN 14126?

When we think about biohazard protective clothing, most pictures are gloves, masks and gowns that healthcare workers wear to shield themselves from infectious diseases and viruses. But have you ever wondered how do we know this clothing works as expected?

This is where the EN 14126 standard comes in. It is a set of test methods and performance criteria specifically designed to assess how well protective clothing can resist the penetration of bacteria, viruses, and other infectious agents.

The EN 14126 standard stands as a vital line of defense, ensuring that protective clothing used against biohazards meets the stringent performance criteria before entering high-risk environments. This rigorous testing process ultimately serves as a shield, safeguarding the lives and well-being of individuals who rely on this critical equipment.

Tests included in EN 14126

EN 14126 is a European standard that specifies performance requirements and test methods for protective clothing against infective agents. The title of the standard is “EN 14126:2003 Protective clothing – Performance requirements and tests methods for protective clothing against infective agents.” It includes the performance requirements against penetration by infective agents.

  • Resistance to penetration by contaminated liquids under hydrostatic pressure.
  • Resistance to penetration by infective agents due to mechanical contact with substances containing contaminated liquids.
  • Resistance to penetration by contaminated liquid aerosols.
  • Resistance to penetration by contaminated solid particles.

Pic 1: The EN 14126 standard ensures the protective clothing against biohazards.

In addition to meeting suit specifications, clothing materials must also fulfill performance requirements regarding protection against biological infective agents, including resistance to penetration resistance, mechanical and chemical durability, as well as specific requirements for seams, joints, and assemblages.

Performance requirements against penetration by infective agents

  1. Resistance to penetration by contaminated liquids under hydrostatic pressure
    When tested for the resistance to penetration by contaminated liquids, it is in accordance with ISO/FDIS 16603 and ISO/FDIS 16604. The test method uses a surrogate microbe under circumstances of constant liquid contact. Protective clothing “pass/fail” determinations are based on the detection of penetration at a specific hydrostatic pressure.
Class Hydrostatic Pressure at Which the Material Passes the Test
6 20 kPa
5 14 kPa
4 7 kPa
3 3.5 kPa
2 1.75 kPa
1 0 kPa

Table 1: Classification of resistance to penetration by contaminated liquids under pressure

2. Resistance to penetration by infective agents due to mechanical contact with substances containing contaminated liquid

When tested for the resistance to penetration with contaminated liquid to mechanical contact, it is in accordance with the annex A in EN 14126 which will be replaced by EN ISO 22610. Both methods address the resistance of materials to wet bacterial penetration.

It is used to determine the resistance of a material to the penetration of bacteria carried by liquid when subjected to mechanical rubbing. The rubbing device applies a defined mechanical force and number of cycles to the material surface. An extracted plate is replaced every 15 mins. cycle to estimate the penetration and final result should be classified according to the levels given in Table 2.

Class Breakthrough Time (t)
6 t ﹥ 75 mins
5 60 mins < t ≦ 75 mins
4 45 mins < t ≦ 60 mins
3 30 mins < t ≦ 45 mins
2 15 mins < t ≦ 30 mins
1 t ≦ 15 mins

Table 2: Classification of resistance to penetration by infective agents due to mechanical contact with substances containing contaminated liquids

3. Resistance to penetration by contaminated liquid aerosols

This test is according to ISO/DIS 22611, a test aerosol containing virus will be sprayed onto the material at a specific pressure and flow rate for a defined duration. After spray cycle, the inner surface of the material is collected and tested to quantify the number of viruses that penetrated the material. The material should be classified based on the test results into the levels of performance given in Table 3.

Class Penetration Ratio (log)
3 log > 5
2 3 < log ≦ 5
1 1 < log ≦ 3

Table 3: Classification of resistance to penetration by contaminated liquid aerosols

4. Resistance to penetration by contaminated solid particles

BS EN ISO 22612:2005 describes a test method for assessing resistance to dry penetration of bacteria. A bacterial suspension is deposited onto the material surface then left undisturbed for a specific period. After the settling period, collecting plate beneath the material is retrieved and extracted bacteria to quantify by standardized method, such as colony forming unit (CFU) counting. The number of recovered bacteria indicates the level of penetration through the material should be classified according to Table 4.

Class Penetration Ratio (log cfu)
3 log cfu ≦ 1
2 1 < log cfu ≦ 2
1 2 < log cfu ≦ 3

Table 4: Classification of resistance to penetration by contaminated solid particle

Performance requirements for materials

The EN 14126 standard plays a crucial role in ensuring protective clothing provides adequate defense against exposure to infective agents. However, this European standard encompasses much more than just establishing antibiological performance criteria.

In addition to specifying resistance requirements against infective agents, EN 14126 also require fabrics and the seams, joins and assemblages of protective clothing to be tested and classified in accordance with the test methods and fulfill the requirements in relevant clauses in EN 14325. This includes abrasion resistance, flex cracking, puncture, tensile, and tear strength among other attributes. Moreover, if protective clothing against chemicals is claimed, and it should also be tested and classified according to the relevant clause in EN 14325.

Whole suit protective clothing requirements

Protective clothing intended for defense against infective agents must first meet the basic health and safety requirements outlined in EN 340. This establishes baseline usability criteria. Beyond this, full protective suits must additionally comply with the performance specifications established in relevant standards for chemical protective clothing. This ensures well-rounded protection against both chemical and biological hazards in high-risk situations.

Critically, EN 14126 also mandates pre-conditioning by simulating real-world usage before testing. If manufacturer instructions indicate the clothing is suitable for cleaning and reprocessing after use, test samples must undergo multiple laundering and decontamination cycles (up to 5 times) as the instructions indicated before all above testing.

Conclusion

Along with biohazard resistance, EN 14126 request critical mechanical and chemical properties stipulated provide well-rounded protective functionality and confidence. It encompasses a holistic approach to ensure the effectivity of protective clothing for high-risk environments against biohazard agents.

In summary, EN 14126 is a widely used standard for protective clothing. When it comes to protection against infective agents like bacteria and viruses, it is important to consider a EN 14126 certified protective clothing. It means the clothing had to pass a various of intense tests to prove it can stand up to biohazard in different work environments.