The EN 14476 is the most common virucidal test that we conduct. It is required in the medical, industrial, and domestic markets, although it is technically a medical standard. Virtually any product that requires a virucidal claim would start with the EN 14476 as the Phase 2 step 1 test. The only exception being if the product is going on to veterinary market, in which case the EN 14675 would be more suitable. Usually, this test is conducted and reported before any other virucidal testing is performed, as it is often regarded as easier to pass than the phase 2 step 2 testing. This means that if these fail, carrying on to further testing may irrelevant. Although for most product types the EN 14476 is optional, it is now actually a mandatory test for instrument disinfection according to the ECHA.
The EN 14476 is a suspension test, which means it is conducted in a suspension of test organism, interfering substance and test product. The interfering substance and the organism make up 20% of this mix so even ‘ready to use’ products are diluted to 80% during the testing. If the product is prediluted before the testing starts, we increase the percentage of product by 1.25 to account for the 80% dilution. In the EN 14476, there is a clause that states you can have a modified test that uses a ready to use product at 97% rather than the usual 80%. We achieve this by concentrating up the inoculum and interfering substance.
As the EN 14476 is a virucidal test, it is quite different to other microbiological tests standards. This is because you have different options to choose from, rather than just having a mandatory set of organisms. With the EN 14476, most product types have three options which are full virucidal activity, limited spectrum activity and enveloped virus activity. In most cases the full virucidal activity is the hardest to achieve as this includes Poliovirus, which is an extremely hard organism to kill. The easiest to achieve would be the enveloped virucidal activity. Different active ingredients have more chance with certain organisms over others. For example, alcohol can usually kill enveloped viruses, but struggles with non-enveloped viruses, and can rarely achieve a limited virus claim. Please call us if you would like to discuss this in more detail.
Virtually any virus can be added on to the EN 14476 to make a specific claim. For example, we can add coronavirus or flu. We are also able to add a wide range of other organisms which you will be able to find on our virus fact sheets, but if the organism you are looking for is not there, please give us a call and we will see what we can do for you.
For a BPR submission, you will need the EN 14476, or another viral suspension test, if you are looking to make a virucidal claim on your product. As with all BPR submissions, you must have three concentrations tested against. These must include the final usage concentration, a concentration that fails the test and then any other concentration. Most commonly people opt for the final concentration, 50% of that and then either 10% or 1% of the end concentration.
The table above shows what the standard states as the test parameters, but often the NHS insist on different conditions. For example, this could be a thirty second contact time, or dirty conditions, even when the standard states otherwise. If you require testing for a specific tender, you should check the requirements of this before testing, this is because other entailments? may also have internal policies which could differ from the standard.