Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants in the medical area – Test method and requirements (phase 2, Step 1) (EN 17126: 2018).
Test accredited by ENAC (National Accreditation Entity).
Test with the certificate of Good Laboratory Practices (GLPs).
This standard describes a test method and the minimum requirements for evaluating the sporicidal activity of chemical products that form a homogenous and physically stable preparation when diluted with hard water or, in the case of ready-to-use products, with water. The products can only be tested at a concentration of 80% or less (97% with a modified method for special cases) since some dilution always occurs when the test organisms and the interfering substance are added. This European standard applies to products used in the medical area in the fields of disinfection of instruments by immersion and disinfection of surfaces by wiping, spraying, flooding or other means. This European standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: - in hospitals, in community medical facilities and in dental institutions; - in school clinics, kindergartens and nursing homes; and it can occur in the workplace and in the home. It may also include services such as laundries and kitchens that supply products directly to patients.
The standard allows to evaluate the specific activity against Clostridium difficile using spores of this microorganism, or the general sporicidal activity when spores of Bacillus subtilis and Bacillus cereus are used. In addition, it allows to use spores of any other additional relevant microorganism. The standard differentiates some parameters of the test according to some specific applications: disinfection of surfaces, disinfection of instruments and disinfection of tissues. For the disinfection of surface allows to choose by the manufacturer between temperatures of 4ºC to 30ºC; a contact time no longer than 15 minutes when surfaces can come into contact with patients, or 60 minutes for other situations; clean conditions (0.3 g of bovine albumin) or dirty (3 g/L of bovine albumin and 3.0 mL/L of erythrocytes). For disinfection of instruments, it must be done at a temperature of 20ºC to 70ºC; a maximum contact time of 60 minutes; clean or dirty conditions with the same interfering substances indicated previously. For textile disinfection the temperature should be between 20ºC and 80ºC; a maximum contact time of 60 minutes; clean or dirty conditions as previously indicated. To consider that the product is sporicidal, the product shall demonstrate at least 4 decimal log reduction.
The product should be tested 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 because they are considered tests controls).
Note: the ready-to-use products, which are not diluted when applied, and do not demonstrate the required reduction, a modified test procedure mat be used in order to test a higher product concentration (97%).