The EN 13727 is the medical phase 2 step 1 test for bacteria. For medical disinfection products this is the most common test we carry out. The EN 13727 is an obligatory standard for any disinfection in the medical area, this includes surface, hand rubs and washed and instrument disinfection. There is also a section in the EN 13727 dedicated to pre surgery hand disinfection for both rubs and washes. Like with other Phase 2 step 1 bacteria suspension tests it is often done before the other obligatory standards to give an indication as to whether a good result could be expected on the step 2 tests. The EN 13727 is similar to the EN 1276 so usually the results will be similar on both tests.
The EN 13727 is a suspension test which means it is carried out 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 product 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 13727 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%. This is done by concentrating up the inoculum and interfering substance.
As with most suspension tests additional organisms can be added to the EN 13727 to support certain claims. Antibiotic resistant bacteria or ‘superbugs’ are especially common to add to the medical tests as they are on the rise in healthcare setting and becoming more resistant to antibiotics by the day. These organisms include things like MRSA and VRE.
For BRP submission of a medical disinfectant the EN 13727 is essential. As for all BPR submissions you must have three concentrations tested. These have to include the final usage concentration, a concentration that fails the test and then any other. Most commonly people opt for the end concentration, 50% of that and the 10% or 1% of that.
The table shows what the standard states as the test parameters but often the NHS will insist on different conditions. This could be 30 second contact time or dirty conditions even when the standards state oterhwise. If you are testing for a specific tender, you should check the requirements of this before testing.