EN 14563 Chemical Disinfectants and Antiseptics - Quantitative Carrier Test for Evaluation of Mycobactericidal or Tuberculocidal Activity of Chemical Disinfectants Used for Instruments in the Medical Field - Test Method and Requirements (Phase 2, Step 2)

EN 14563 Chemical Disinfectants and Antiseptics - Quantitative Carrier Test for Evaluation of Mycobactericidal or Tuberculocidal Activity of Chemical Disinfectants Used for Instruments in the Medical Field - Test Method and Requirements (Phase 2, Step 2)

The EN 14563 standard, a European standard, describes the requirements for the mycobactericidal or tuberculocidal activity of chemical disinfectant products, which when diluted with hard water or, in the case of ready-to-use products, form a homogeneous, physically stable preparation with water, and defines a test method.

EN 14563 Chemical Disinfectants and Antiseptics - Quantitative Carrier Test for Evaluation of Mycobactericidal or Tuberculocidal Activity of Chemical Disinfectants Used for Instruments in the Medical Field - Test Method and Requirements (Phase 2, Step 2)

The standard in question is valid for products used for disinfection of instruments by immersion in the medical field, although they are not covered by the EEC/93/42 directive for medical devices. This test method is applicable to areas and situations where disinfection is medically indicated. The most common environments are:

  • Hospitals, community health facilities and dental practices
  • Clinics of schools, kindergartens and nursing homes
  • workplaces and homes

This test method also covers service areas such as laundry and kitchen that provide products directly to patients.

Meanwhile, another European standard, EN 14885, contains details for using the interrelationship of various tests and recommendations.

A test suspension of mycobacteria in a solution of interfering substances during testing is spread on a glass carrier. After drying, the carrier is immersed in the delivered product sample or diluted with hard water, for ready-to-use products. The carrier is held at 60 degrees for 20 minutes. 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. The test is carried out using mycobacterium avium and mycobacterium terrae or mycobacterium terrae alone as test organisms. Optional contact times and temperatures are included in the standard. Additional interfering substances may be used during testing.

Quantitative carrier testing services for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for medical instruments within the scope of EN 14563 standard, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors. also gives.

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