EN 16616-Chemical-thermal textile disinfection. UNE-EN 16616: 2015. Chemical disinfectants and antiseptics. Chemical-thermal textile disinfection. Test method and requirements (phase 2, step 2).
This standard describes a test on germ carriers to establish whether a disinfection product, or combination of products, intended for the treatment of contaminated textile fabric, intended to act in a single wash, has or does not have the necessary microbicidal activity. The standard aims to validate only the disinfection part of the laundry process. This laboratory test takes into account the practical conditions of application of the product, including the contact time, the temperature, the test microorganisms and the interfering substances, that is, the conditions that may influence its action in practice. Each effective dose of the chemical disinfectant found by this test corresponds only to the chosen experimental conditions. When the actual conditions differ from those specified by the standard, additional tests should be conducted to determine the effective dose. The instructions for use are the responsibility of the manufacturers of detergents or disinfectants.
The test uses a washing machine with specific characteristics specified by the standard, which allows to specify all the characteristics of the washing. The instructions of the supplier must be sufficient to allow the method described in the standard to be carried out completely.
This standard applies to the areas and situations for which disinfection is indicated. Such indications occur during the care of the patient, for example: a) in hospitals, in community medical facilities and in dental institutions; b) in schools, kindergartens and nursing homes; c) institutions in which patients are accommodated, who may suffer from communicable diseases; d) other applications in which the hygienic treatment of textile fabric is necessary, for example, processing of food, hotels or work clothes such as that of workers in the pharmaceutical industry, laboratories, food areas and similar institutions.
This is a phase 2, stage 2 procedure, so the product under test must have passed the phase 2, stage 1 tests, in addition to this test following the EN 13727, EN 13624 and EN 14348 standards under the conditions of following test: 1) the temperature recommended by the manufacturer; 2) the contact time recommended by the manufacturer; 3) dirty conditions and 4) the recommended reduction for disinfection of the instruments. For products used at > 60°C, EN 13624 and EN 14348 should be previously complied with, using Aspergillus brasiliensis and M. avium, respectively.
For processes with temperatures < 60ºC, the thermochemical disinfection process of a textile fabric is considered effective when in three test series (within a given time, with a recommended dose, and a recommended temperature and liquid index) achieves a logarithmic reduction of bacteria inside and outside germs above 7, a logarithmic reduction of Candida albicans and Aspergillus brasiliensis of 6, and a logarithmic reduction of mycobacteria (M. avium and / or M. terrae) of 7 In addition, no microorganism should be detected in 100 ml of the washing / disinfecting liquid. As a minimum requirement, the bactericidal and levuricidal activity should be evaluated using the following test microorganisms: for the bactericidal activity Pseudomonas aeruginosa, Escherichia coli (K12), Staphylococcus aureus and Enterococcus hirae and for the levuricidal activity Candida albicans. If an additional fungicidal activity is claimed, Aspergillus brasiliensis should also be used as a test microorganism. If additional tuberculicidal activity is claimed, Mycobacterium terrae should be used as a test microorganism. If a mycobactericidal effect should be confirmed, it is also necessary to carry out the test with Mycobacterium terrae and Mycobacterium avium.
For processes with temperatures ≥ 60ºC, it is considered to be effective when in three test series (within a given time, with a recommended dose, at a process temperature ≥ 60ºC and a defined liquid index) a logarithmic reduction of Enterococcus faecium is reached on the inside and outside of the germs carriers above 7. In addition, no microorganism has to be detected in 100 ml of the washing / disinfecting liquid. This includes fungicidal, mycobactericidal and tuberculicidal activities. In addition to the mandatory test microorganisms, additional test microorganisms may be selected according to the practical use considered for the product.
The tests use cotton cloth germs carriers that are contaminated with a test suspension of microorganisms in sheep defibrinated blood. After drying the germs, they are placed in cotton bags and then subjected to the disinfection process in the washing machine at temperatures of t < 60°C or t ≥ 60°C.