BS EN 16777:2018

BS EN 16777:2018 (Phase 2 step 2)
General/surface disinfection
Mandatory test Organisms
Full viricidal activity
• Adenovirus
• Norovirus
Viricidal activity against enveloped viruses
• Vaccinia virus
Test Temperature
Between 18°C and 25°C
Contact time
No longer than 5 or 60 minutes
Clean or Dirty depending on manufacturers usage instructions
Log reduction required to receive a pass
>4 Log

The EN 16777 is the most common phase 2 step 2 virology test that we carry out.  Although it was written for the medical market it can be used in the veterinary and the domestic/industrial market.  This is because it is one of the only phase 2 step 2 virology tests.  There is another standard called the EN 17111, but this is for instrument disinfection.  All other products would usually fall under the EN 16777.  Usually before any step 2 testing is carried out the relevant step 1 test would be completed as if the step 1 fails the step 2 has very little chance of passing and they are usually bigger tests.

The EN 16777 is a surface test rather than a suspension test which means we do not need to dilute a ready to use product at all.  For the EN 16777 we take a known number of organisms and interfering substance in 50µl of solution and add then to a small stainless disk. The disk looks like a smooth penny.  We then dry the disk.  Once the disk is fully dry, we add 100µl of product onto the surface over the organism.  This is then left for the contact time.  Once the contact time is up, we remove the organisms off the disk.  We then add the remaining virus to its cells to grow up.  After being incubated the remaining organisms will be counted (if there is any) and a log reduction is worked out.  We get the log reduction by carrying out the test with water instead of a disinfectant.  The difference between the water control and the test product gives you the log reduction.

Virtually any virus can be added to the EN 16777 to make a specific claim.  For example we can add coronavirus or flu.  There are many other organisms that can be added and some of the popular ones will be on our virus fact sheets.  If the thing you are looking for isn’t here please give us a call and we can see what we can do for you.

As the EN 16777 is a viricidal test it is quite different to other microbiological tests standards.  This is because you have different options to choose from rather than just having the set organisms that are mandatory.  With the EN 16777 you have two options which is full virucidal activity and enveloped virus activity.  In most cases the full virucidal activity is the hardest and the easiest would be the enveloped viricidal activity.  Polio isn’t included in the EN 16777 as the test requires organisms to be dried and Polio dies when dried. Different active ingredients have more chances with some organisms than others.  For example, alcohol can usually kill enveloped but struggles with non-enveloped viruses and can rarely achieve a limited virus claim.  We can discuss this in more detail if you call us.

It may depend on your product whether or not BPR would insist upon the EN 16777.  It is more likely among disinfectants intended for the medical area that organisations such as the NHS would insist upon it.  Recently in some of the NHS tenders it has been a requirement.

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 otherwise.  If you are testing for a specific tender, you should check the requirements of this before testing.

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