EN 14476: 2013 + A2: 2019. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (Phase 2, step 1) under specific conditions for PT5 of BPR.
Test accredited by ENAC (Spanish National Accreditation Entity), for standard mandatory viruses and additionals.
Test with the certification of Good Laboratory Practices (GLPs).
This test is performed according to EN 14476: 2013 + A2: 2019 standard adapted according to the specific conditions of the BPR Guidance. The test is performed with the mandatory viruses Adenovirus type5, Murine norovirus and Enterovirus (for example Coxsackievirus B4 or B5). The assay temperature is 15°C and the time of contact and the soling conditions depend on the intended use of the PT5 product, as indicated in the table below.
|
Intended use of the product to evaluate |
Contact time |
Soiling conditions |
|
PT5 Drinking water suppliers and their water distribution systems |
Max 30 min |
Clean (2 mg DOC/L)for secondary disinfection /dirty (15 mg DOC/L) for primary disinfection. |
|
PT5 Raw water for individuals supply (1-2 premises) |
Max 30 min |
Dirty (15 mg DOC/L) |
|
PT5 collective drinking water systems |
25 min |
Clean (2 mg DOC/L) |
|
PT5 water in reservoirs |
As claimed |
Clean (2 mg DOC/L) for origin from drinking water supplier only/ dirty (15 mg DOC/L) for origin raw water. |
|
PT5 Water of undefined quality for small scale use (up to 5L/ person/day). |
Max 30 min |
Dirty (15 mg DOC/L) |
|
PT5 Water for animals |
Max 30 min (for continuous use the contact time is max 30 minutes. For reservoir water for animals the contact time should be as claimed). |
Clean (2 mg DOC/L) for origin from drinking water supplier only/ dirty (15 mg DOC/L) for origin raw water. |
The product must be assayed at least at three concentrations, including one in the non-active concentration range and another in the active concentration range (these two last concentrations are selected by the testing laboratory). To consider the product as virucidal a 4 logarithmic reduction in the infectivity of viruses must be obtained.