The EN 1500 is a phase 2 step 2 test for hand sanitisers for all markets apart from if the intended use is for pre surgery in which case the EN 12791 is required. The EN 1500 is mandatory, and a hand sanitiser should not be sold without it. The EN 1500 is an in-vivo test and therefore only has one test organism which is an inactive strain of E.coli.
The EN 1500 test is an in-vivo test meaning it is carried out on volunteers’ hands rather than in a suspension or on a hard surface. Due to the fact it is tested on volunteers hand its different to other tests in as much as a log reduction isn’t the decider as to whether the product has passed or failed. To get a pass or fail it must be compared to a reference product which is 60% propan-2-ol. To carry out the test we assemble a group of 18-22 volunteers. We then clean the hands to remove proteins and bacteria, so all hands start off pretty much the same. Once the hands are clean we immerse them in a solution of E.coli which is grown in a enrichment broth. Once the hands have been fully immersed, we then take them out and let them dry. Once the hands are dry we added the test product on and the volunteers use the product for the contact time while focusing on the finger tips as this is what is tested. After the contact time is up the volunteer put their fingers in a neutralizer. We then take the neutraliser and test to see how any organism are left after using the hand sanitiser. We do the same process for the reference product apart from on the reference product there are two applications of product rather than one which increases the log reduction. We can do this for the test product as well if a customer requires it.
Unlike most other standards the test organism on the EN 1500 cannot be changed. As it is being put on volunteers’ hands, we have to ensure that it is safe even though we disinfect the hands after the testing is completed. Due to this we do not use other organisms as they could be potentially dangerous.
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 into the NHS as they usually will only accept 30 second contact times.