The EN 12791 is the phase 2 step 2 test for hand sanitisers and washes that are to be used by healthcare professionals pre surgery. All products that are intended to be used pre-surgery would need this test and a buyer would be unlikely to purchase a product for this purpose without a pass on the EN 12791. The EN 12791 is unlike any other biocidal test as there is no added test organism. Instead, the natural microbial skin flora on a volunteer’s hands is measured before and after using the product and the reference solution. There are also two different pass criteria in the EN 12791, they are the normal test that means you can claim the EN 12792 and then the sustained effect. The sustained effect mean that the product has continued to work over a period of time which is 3 hours. This is useful in surgery settings as it means your skin flora is kept to a minimum decreasing the risk to the patient of infection. The reference product for the EN 12791 is 60% propan-2-ol which is the same as in the EN 1500. To achieve a pass on the EN 12791 the product must be as good as the alcohol after 3 hours and to make a sustained effect claim the product must be significantly better.
Although the EN 12791 is an in-vivo method it is different from the other ones we run. For the EN 12791 we take a pre-value from the hands without any additional organisms. We then use the product and after 3 hours we take a post value. We do the same for the reference product which is the propan-2-ol. For the EN 12791 we need a group of around 25 volunteers but there is a stipulation in the standard that no volunteers can use any antibacterial products for 3 days prior to the testing. This included household cleaners, soap and sanitisers. During the coronavirus pandemic due to the huge number of antibacterial products being used and the government guidelines this test was suspended.
Due to the fact that the EN 12791 is specially looking at the action of the product on skin flora we can not add a test organism in. If you are looking for a log reduction against a controlled bacteria then you would be better looking at the EN 1499 or the EN 1500.
For BPR submission only one concentration is required to be tested and this would be the end usage concentration. If you are selling the product at different dilutions, you would need to have each one tested.
The table shows what the standard states as the test parameters but often the NHS will insist on different conditions. This is especially true when selling hand sanitisers and soaps into the NHS.