Interpretation of EN 14126 and ISO 16604 Tests for Medical Protective Clothing

EN 14126 is a standard for anti-infection clothing. It includes four tests to evaluate the ability of fabrics to resist bacterial or viral infections, such as body fluids or contaminated surfaces. For those involved in choosing work clothes for this kind of protection, it is vital to understand this criterion, especially since there is considerable confusion around. 

What does the certification of this standard tell you and how to use it? Certification en 14126?

In other words, the presence of the hieroglyphic clothing label and the '-b' suffix tells you. There is nothing about the types of infectious diseases, it is suitable for prevention. Different viruses and bacteria have different behaviors and modes of transmission, and different ways of contamination will be used. Therefore, the standard contains four tests, each of which measures resistance to different types of pollution (the details and classification of the different tests are shown in the table at the bottom of this blog). With this in mind, a garment can be certified as EN 14126, but it may only be tested to one of the four tests and reach the lowest classification; or it may have been tested for all four tests, and The highest classification is reached in each test. The basic information notified on the label will be the same. In addition, if-for example-a garment is only tested according to ISO 22612-the penetration of contaminated dry particles is tested, this has little to do with the protection of the 2019-nCoV coronavirus. This is because it is mainly spread through water droplets caused by coughing and sneezing (although like other cold and flu viruses, it can also survive on contaminated surfaces), which is processed by iso 22610 (now replaced by EN 14126) : Annex A). 

Therefore, the certification of EN 14126 alone does not indicate that a piece of clothing is suitable to protect it from this or any other infectious agent. To judge whether a piece of clothing is suitable for the protection you need, you must: 

1) understand the pollution pathway in a specific environment (or related to a specific infection) and 

2) check the instructions (or data sheet) of the clothing to find out that it has What tests have been taken and whether they are relevant. 

What are the key tests within the scope of the standard? 

Of these four tests, ISO 16604 is particularly important in this (and any virus protection) case. but why? Each of these four tests uses a culture medium contaminated with bacteria. The table below shows the type of each test, the size of the contaminants used, and the known size of the 2019-nCoV coronavirus. Note: This information is directly taken from the EN standard. It can be clearly seen that only the iso 16604 test uses a pollutant-a bacteriophage (that is, a virus that is parasitic by infecting bacteria. In this case, according to The standard choice of Phi x 174 is very small), which is much smaller than the coronavirus that fills news now. The bacteria used in other tests are much larger than the coronavirus. 

Therefore, ISO 16604 is the only test that provides a clear indication of effective resistance to infectious agents that penetrate to this scale. Therefore, in summary, the designated person for protective clothing should look for clothing that not only passes EN 14126 certification, but also achieves a good classification in ISO 16604 testing. The ISO 16604 and ISO 16603 EN 14126 standards only contain four tests, instead of the five tests recommended by some manufacturers. 

A common claim of some manufacturers and suppliers is that their clothing is suitable because it meets the classification in ISO 16603. This is incorrect; there is no classification in the standard of ISO 16603 test results, and ISO 16603 is a test lower than 16604: it is not meant to indicate any level of protection. The standards in this regard are very clear. Although the ISO 16603 test is for reference, it is clearly stated that this is a 'pre-cursor' test to be carried out in preparation for ISO 16604. The key test (ISO 16604) measures the 'breakthrough' pressure of the medium containing the phage. In order to confirm the penetration of the virus, a culture must be grown from any infiltration medium to confirm the penetration of the virus. ISO 16603 exists purely to reduce the work and cost of ISO 16604. In order to avoid testing under every pressure until 'pass' is confirmed, ISO 16603 uses artificial blood in a simple visual penetration test to estimate the pressure that may occur in ISO 16604. Then, the ISO 16604 test can be carried out under this pressure as a starting point. However, the 16603 test does not use any contaminants (like other tests), and the classification table only applies to the results of ISO 16604. Article 4.1.4.1 of the standard clearly confirms this point. (In fact, it is usually the case that products that claim to be classified by the 16603 International Organization for Standardization do so because they have passed the ISO 16604 test. Therefore, for any clothing that claims to be classified as 16603, it is worth checking the test results of 16604. .) In terms of design, the garment should also be certified as at least EN 14605 Type 4, which requires sealed seams and sealed zipper covers to minimize the possibility of passing these routes... In other words, a garment marked with Type 4b.

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