The European standard EN 14476
General
The EN 14476 European standard (“Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine”) was first ratified in France by the Managing Director of AFNOR on July 20th, 2005 and came into force on August 20th, 2005.
This standard is now tending to replace the pre-existing French NFT 72-180 standard.
The aim of this standard is also to demonstrate a 99.99% reduction in viral load. Special care has been taken to simulate the test product's real conditions of use as closely as possible.
Requirements
The product should reduce the number of infectious units of two viral species by a factor of at least 104. In this standard, the product's test concentration has to be bounded by 2 other concentrations (one efficient and the other non-efficient). The test conditions are thus as follows:
- 20°C and a 60-minute contact time for disinfectants for use on surfaces and materials.
- 20°C and 30-second & 1-minute contact times for virucidal soaps and hand disinfection gels.
Experimental methods
A viral suspension is added to each of the 3 concentrations of the test product (non-efficient, test, efficient). At the end of the contact time, the virucidal activity is immediately stopped by dilution or Sephadex gel filtration (depending on the method selected during preliminary assays). A positive control (formaldehyde) has to be included in each experiment. The samples and controls are then titrated and the virucidal activity can be assessed. Duplicate experiments are carried out for each virus to be tested.
It should be noted that these experiments have to be carried out in either “clean” conditions (with PBS or BSA) or “dirty” conditions (with BSA and erythrocytes).
Viruses
The following viral strains of human origin are used to perform the test.
- Picornaviridae - enterovirus, polio virus (type 1), SABIN strain, grown on VERO cells.
- Adenoviridae - adenovirus type 5, grown on KB cells.
Other viruses are available on request and can be tested according to the EN 14476 requirements: HIV, HAV, BVDV (a model for hepatitis C virus), influenza, etc.
