EN 14563 Chemical Disinfectants and Antiseptics - Mycobactericidal or Tuberculocidal Activity of Chemical Disinfectants Used for Instruments in the Medical Field

EUROLAB laboratory provides testing and compliance services within the scope of EN 14563 standard. The EN 14563 standard specifies a test method and minimum requirements for the mycobactericidal or tuberculocidal activity of chemical disinfectant products that, when diluted with water, form a homogeneous, physically stable preparation in the case of hard water or ready-to-use products.

This European Standard applies to products used for immersion disinfection of instruments in the medical field, even if they are not covered by the EEC/93/42 Directive on Medical Devices. This European Standard applies to areas and situations where disinfection is medically indicated. Such manifestations occur in patient care, for example:

In hospitals, community health institutions and dental institutions,
It can occur in clinics of schools, kindergartens and nursing homes, at work and at home.
It may also include services such as laundry and kitchens that provide products directly to patients.

This European Standard specifies a carrier test to determine whether a chemical disinfectant used in instruments (surgical instruments, anesthetic equipment, endoscopes, etc.) has mycobactericidal or tuberculocidal activity in the scope defined area.

The laboratory test closely simulates practical application conditions, including pre-drying mycobacteria, contact time, temperature, test organisms and interfering substances on a carrier, i.e. conditions that, in practical cases, may affect the efficacy of chemical disinfectants.

Mandatory requirements are intended to cover general purposes and allow reference between laboratories and product types. Each use concentration of the chemical disinfectant found by this test corresponds to the defined experimental conditions. However, for some applications the recommendations for use of a product may differ and therefore additional test conditions must be used.

When the product is tested according to Item 0,3 under simulated clean conditions (3,0 g/l bovine albumin solution) or simulated dirty conditions (3,0 g/l bovine albumin solution plus 5 ml/l washed sheep erythrocytes). ) should show at least a decimal log (lg) reduction in 20-counts, according to their practical application and under mandatory test conditions (one or two selected test organisms, 60 °C, 4 minutes).

The test suspension of mycobacteria in a solution of interfering substances is spread on a glass carrier. After drying, the carrier is immersed in the delivered product sample and/or diluted with hard water (for ready-to-use products: water). The carrier is held at 60 °C ± 10 °C for 20 minutes ± 1 s (forced test conditions). At the end of this contact time, the carrier is transferred to a neutralizer containing glass beads. Mycobacteria should be separated from the surface by shaking. The number of surviving mycobacteria in each sample is determined and the reduction calculated.

EUROLAB, with its more than 25 years of experience, state-of-the-art accredited laboratories and expert team, helps you get precise and fast results. Do not hesitate to contact our laboratory for your testing and certification requests.