Chemical disinfectants and antiseptics - Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area - Test method and requirements (phase 2/step 2). (Standard guideline EN 16777: 2019)
Test accredited by ENAC (National Accreditaton Entity).
Test with the certificate of Good Laboratory Practice (GLPs).
This European Standard describes a test method and the minimum requirements for the virucidal activity of chemical disinfectants that form a homogeneous, physically stable preparation when diluted in hard water or, in the case of ready to use, in the water. This European Standard applies to products used in human medicine for disinfection of non-porous surfaces, including surfaces of medical devices, without mechanical action. This European Standard applies in areas and situations where disinfection is indicated in human medicine. Such indications can be found in the context of patient care, for example: in hospitals, medical centers and dental practices; in infirmaries of schools, kindergartens and old people's homes; and can also meet at workplaces or at home. They may also concern services such as laundries and kitchens that provide products directly to patients.
The product, when tested in accordance shall result in a logarithmic reduction in the viral titre of the test strains of Adenovirus and murine Norovirus of at least 4 logarithms (log). As indicated in EN 14885, to be able to claim virucidal activity against enveloped viruses, the product must meet both the requirements of EN 14476 and prEN 16777 with Vaccinia virus; in order to qualify for “Limited spectrum virucidal activity”, it must meet the requirements of these two standards with Adenovirus and Murine norovirus. However, in order to qualify for “General virucidal activity”, the product must meet the requirements of EN 14476 with Poliovirus, Adenovirus and Murine Norovirus, and prEN 16777 with Adenovirus and Murine Norovirus, since poliovirus does not not resistant to drying. Virus that must be tested for EN 14476 are: Poliovirus, Adenovirus, Murine Norovirus; Limited Virucidal Activity: Adenovirus and Murine Norovirus; Virucidal activity against enveloped viruses: Vaccinia virus. Poliovirus cannot be used for surfaces testing according to EN 16777 because of drying problems that inactivate the virus. In EN 16777 test, a virus suspension in a solution of interfering substances is deposited on a stainless steel test disc and dried. One or more additional viruses may be tested, if relevant.
The temperature of assay must be chosen between 4°C and 30°C, as recommended by the manufacturer, but not more than 5 min or 60 min. The contact times of the surface disinfectants indicated should be chosen on the basis of the practical conditions of use of the product. The recommended contact time for the use of the product is the responsibility of the manufacturer. Products that are intended to disinfect surfaces likely to come into contact with the patient and/or medical personnel and surfaces frequently touched by different persons, which leads to the transmission of microorganisms to the patient, must be tested with a contact time of 5 minutes maximum. The same conditions apply when the contact time of the product has to be limited for practical reasons. Products intended for surfaces other than those mentioned above may be tested with a contact time of up to 60 minutes. For clean surfaces the interference substance is bovine albumin solution at 0.3 g/L, and for dirty condition bovine albumin solution at 3.0 g/L plus 3 ml of erythrocytes. Where appropriate (specific uses), additional specific virucidal activity shall be determined under other conditions of time, temperature and interfering substances, in order to take into account the specific conditions of use. As regards the additional conditions, the concentration thus defined may be lower than that obtained under the minimum test conditions.