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Interpretation of medical protective clothing EN 14126, ISO 16604 test test

by:GESTER Instruments     2022-09-04
EN 14126 is a standard for protective clothing, and it includes four tests to assess the ability of fabrics to resist bacterial or viral infections, such as bodily fluids or contaminated surfaces. For those involved in the selection of workwear for this protection, understanding this criterion is critical, especially since there is quite a bit of confusion surrounding it. What does certification to this standard tell you and how to use it? Certification en 14126? That is, pictographic clothing labels and“-b”The presence of the suffix tells you that. There is nothing about the kind of infectious disease, it is suitable for prevention. Different viral and bacterial infections behave and spread differently and will use different routes of contamination. Therefore, the standard contains four tests, each of which measures resistance to different types of contamination (the details of the different tests, along with their classification, are shown in the table at the bottom of this blog). With this in mind, a garment may be certified to EN 14126, but may only be tested to one of the four tests and meet the minimum classification; or it may have been tested to all four tests, and The highest classification was achieved in each test. The basic information on the label notifying the certification will be the same. Furthermore, if - for example - a garment is only tested to ISO 22612 - to detect the penetration of contaminated dry particles, this has little to do with protecting the 2019-nCoV coronavirus. This is because it is mainly transmitted through water droplets caused by coughing and sneezing (although like other cold and flu viruses it can also survive on contaminated surfaces), which is handled by ISO 22610 (now superseding EN 14126 : Annex A). Therefore, certification to EN 14126 alone does not indicate that a garment is suitable for protection against this or any other infectious agent. To judge whether a garment is suitable for the protection you need, you must: 1) understand the pathways of contamination in a particular environment (or be associated with a particular infection) and 2) look at the garment's directions for use (or data sheet) to find out if it has ever been Which tests have been taken, and whether they are relevant. What are the key tests within the scope of the standard? Of the four tests, ISO 16604 is particularly important in this (and any virus protection) case. but why? Each of the four tests used a medium contaminated with bacteria, and the table below shows the type of each test, the size of the contaminant used, and the known size of the 2019-nCoV coronavirus. NOTE: This information is taken directly from the EN standard and it is clear that only the iso 16604 test uses a contaminant - a bacteriophage (i.e. a virus that parasitizes by infecting bacteria, in this case according to The standard choice of the Phi x 174 is small), which is much smaller than the coronavirus that fills the news right now. Other tests use bacteria much larger than the coronavirus. Therefore, ISO 16604 is the only test that provides a clear indication that it is effective against an infectious agent that penetrates this scale. So, in conclusion, specifiers of protective clothing should look for clothing that is not only EN 14126 certified, but also achieves a good classification in the ISO 16604 test. The ISO 16604 and ISO 16603 EN 14126 standards contain only four tests instead of the five suggested by some manufacturers. A common claim of some manufacturers and suppliers is that their garment is suitable because it meets the classification in ISO 16603. This is incorrect; there is no classification in the standard for ISO 16603 test results, which is a lower test than 16604: it is not intended to indicate any level of protection. The criteria for this are clear. Although the ISO 16603 test is a reference, it is explicitly stated that this is a“front cursor”Tests will be conducted in preparation for ISO 16604. The key test (ISO 16604) measures the“breakthrough”pressure. To confirm viral penetration, a culture is grown from any penetration medium to confirm viral penetration. ISO 16603 exists purely to reduce the work and cost of ISO 16604. To avoid testing at every pressure until confirmed“pass”So far, ISO 16603 uses artificial blood in a simple visual penetration test to estimate the pressure that can occur in ISO 16604. Testing to ISO 16604 can then be performed at this pressure as a starting point. However, the 16603 test does not use any contaminants (like the other tests) and the classification table applies only to the ISO 16604 results. Clause 4.1.4.1 of the standard clearly confirms this. (In fact, and often, products claiming a 16603 ISO classification do so because they pass the ISO 16604 test, so for any garment claiming a 16603 classification, it's worth checking the 16604 test results .) In design, garments should also be certified to at least EN 14605 Type 4, which requires sealed seams and sealed zippered lids to minimise the possibility of passing through these routes…In other words, a garment marked Type 4b.
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