With outbreaks of Avian flu now identified in several European countries including the UK this is likely to be a growing story in early 2017 – and we will be publishing our advice on suitable protective clothing in the new year.
However, as was the case during the Ebola Crisis two years ago, there remains a serious misunderstanding of the tests and classifications in the important EN 14126 standard (Clothing for Protection against Infective Agents) with some manufacturers claiming classification for the ISO 16603 test referenced. This is either a misunderstanding or a misrepresentation of the standard and in the worst case could lead to serious consequences. Correct understanding of EN 14126 is important in the selection of appropriate protective clothing and this blog explains the facts.
EN 14126 contains four relevant, classified tests – and not five as some claim. Five tests are listed, but the first (ISO 16603) is purely used to indicate a starting point for conducting the ‘real’ test for protection against infected blood and body fluids, ISO 16604. The classification table for this relates ONLY to the ISO 16604 test, there is NO CLASSIFICATION for EN 16603 and claiming such classification is meaningless; it is not a test that indicates any proof of protection.
The classifications for ISO 16604 relate to the pressure at which penetration occurs. The higher the pressure the higher the class. ISO 16603 is used to indicate an initial pressure at which penetration is likely to first take place in ISO 16604: this avoids having to test at all pressures in the 16604 test, starting with zero until penetration takes place, so making the testing procedure more manageable and less time consuming. ISO 16603 is NOT intended to be a test to define any level of protection in itself. This is further evidenced by the fact that some fabrics may apparently gain a classification IF it is (incorrectly) applied to the results of ISO 16603 - and yet will be unclassified (i.e. fail to meet the minimum classification) in the "real" 16604 test.
So if manufacturers claim a classification to ISO 16603 then one can only assume it is a result of a misunderstanding of the standard.
If you doubt this then note this quotation below in clause 220.127.116.11 from the standard itself:
“18.104.22.168 Resistance to contaminated liquids under hydrostatic pressure
When tested in accordance with ISO FDIS 16603 and ISO/FDID 16604 the materials shall be classified according to the levels of performance given in Table 1 [not shown here] as obtained in the bacteriophage test (ISO/FDIS 16604).
NOTE: The synthetic blood test (IS/FDIS 16603) is used for screening purposes i.e. to predict the level where strikethrough can be expected when performing the bacteriophage test (ISO/FDIS 16604)”
I have highlighted the key phrases and it is unambiguous: Table 1 classification refers to results obtained in in ISO 16604 and not 16603. There is no classification table for ISO 16603. Further, the clause clearly explains that ISO 16603 is used for screening purposes in preparation for ISO 16604 only.
The conclusion for those involved in garment selection is that where protection against infections presented in blood and other body fluids (the case in both Avian Flu and Ebola) users need to look for classification under ISO 16604 and not 16603. Any claimed classification to ISO 16603 is not correct and it does not give any indication of suitable protection.
For a more detailed analysis of the EN 14126 standard including why ISO 16603 is a unsuitable for indication of any level of protection, download the our Avian Influenza Virus Protective Clothing Guide by clicking here.