With the World Health Organisation (WHO) declaring the Ebola outbreak in the Democratic Republic of Congo an international emergency on 17 July 2019, now seems a good time to update and clarify the important EN 14126 standard, especially given the amount misleading information about it that has been circulated over the last few years.
Firstly, EN 14126 relates to requirements and test methods for clothing used to protect against infectious agents. It contains four (not five) tests against various types of contamination as detailed in the table below.
A certified garment can be identified by the inclusion of the “bio-hazard” pictogram along with its garment “Type” – that is, Type 1,3,4,5 or 6 with the added suffix “-B” (Type 3-B, Type 4-B etc) on its label.
However, nothing in the standard requires the fabric to be tested against all four tests in order for it to be certified; a garment could be tested to only one and classified at the lowest standard.
For this reason, when assessing protection against any particular agent in a specific application, more needs to be done than simply confirm that a garment is EN 14126 certified.
As the standard advises in its introduction, users need to conduct a risk analysis to identify likely routes of contamination and the circumstances in which contamination may occur, such as pressurised liquid (ISO 16604), liquid aerosols (ISO 22611) and so on. In doing so, users can identify which tests in EN 14126 are relevant, and what performance class is necessary, ensuring that the selected garment is subject to the right testing parameters and in the required class.
For example, a Type 6-B garment marked as certified to EN 14126 is of little use in an application involving Ebola (which is transmitted through contact with body fluids) if it has only been tested against the ISO 22612 – the contaminated solid particulates test. A garment tested against the all-important EN 16604 is what is required. Also, a classification according to 14126- Annex A (or EN 22610) to indicate resistance against mechanical contact with wet contaminated surfaces might also be relevant.
Whilst detailed information on which tests the garment has been certified and the classes achieved are not available from the label, accompanying User Instructions should provide everything needed and is mandatory as per the standard.
So what has been the confusion over EN 14126?
The main source of misunderstanding is the relationship between the ISO 16603 and ISO 16604 tests. Some manufacturers have been claiming EN 16603 classification but ignoring EN 16604. Here’s what the standard states:
220.127.116.11 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 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)”
It's clear, then, that the 16603 test is not a classified test and is not intended to indicate the level of protection offered by a fabric.
Furthermore, a key difference between 16603 and the four actual tests is that it identifies a "strike-through" pressure only by visual monitoring and not, as used by the other tests, through the growth of bacteria on the reverse (penetrated) side of the fabric.
In other words, the 16603 test is much less stringent than the other tests and is not a reliable indicator of protection. It is purely a “precursor” test for ISO 16604 and is designed to identify a “starting” pressure for use in the latter test. It saves time by avoiding the need to run a 16604 test at the lowest pressure and working upwards by starting at the pressure indicated by 16603 and working back.
The only real classification for protection against contaminated fluids at pressure is that based on an ISO 16604 test.
Despite this, some manufacturers continue to quote classification (using the ISO 16604 table) according to ISO 16603. Clearly this isn't what the standard states and can only be the result of a misunderstanding which could be very misleading for users, who might understandably believe they are well protected when they may not be; a false classification based on the incorrect ISO 16603 test is not an adequate indication of protection and in applications involving hazards such as Ebola the result could be catastophic.
Thus, any garment selected for protection against Ebola – or any other biological agent transmitted in or via fluids – should, as a minimum, meet the following criteria:
- EN 14126 certification
- Tested and classified according to (at least) ISO 16604 (not 16603 which is not required and has no classification in the standard)
Alternatively, for other applications, the garment is tested and classified to at least one of the four tests detailed in EN 14126, with the most appropriate test for the specific application being applied and to the required classification.
3. Tested and certified to a whole garment standard according to the requirements of the application; i.e., to Type 1,3,4,5 or 6
During the Ebola outbreak in West Africa, the Department for International Development (which was managing the UK relief effort) agreed with us that garments should be at least Type 4-B. Type 6, which allows permeable fabric and stitched seams, was decreed insufficient. Type 3, which provides resistance against strong liquid jet spray, was considered excessive.
Taking this into account, the most protective garment for workers in close contact with Ebola patients would be Type 4-B certified and of the highest class against ISO 16604.
And we have developed a garment that meets all of these requirements: the ChemMax 1EB.
The garment was developed in response to a request from the Department for International Development in 2015. ChemMax 1EB garments are now available from stock. These proposals were outlined in much greater detail in our advice document published during the 1015 Ebola outbreak