EN 12791 Chemical Disinfectants and Antiseptics - Surgical Hand Disinfection - Test Method and Requirements (Phase 2, Step 2)

Standard EN 12791, a European standard, describes requirements and defines a test method to determine whether a product for surgical hand rub and hand washing, when used for the treatment of clean hands of volunteers, reduces the release of resident and ultimately present transient microbial flora in the hand.

EN 12791 Kimyasal Dezenfektanlar ve Antiseptikler - Cerrahi El Dezenfeksiyonu - Test Yöntemi ve Gereklilikler (Faz 2, Adım 2)

This standard applies to surgical handrub or handwash products for use in 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.

When starting this test, a certain hand washing (prewash) is performed on the volunteers to remove most of the transient flora and foreign matter that will affect the preliminary values. While testing, the following samples are taken from the hands for bacterial count:

  • Immediately after prewash (before treatment with a product or reference handrub)
  • Immediately after the surgical hand scrub or washing procedure
  • 3 hours after surgical hand scrub or washing procedure

The ratio of values ​​(reduction in numbers) obtained before and after treatment represents a measure for the antimicrobial activity of the product tested. The immediate effect is characterized by the reduction achieved immediately after treatment with the product. The 3-hour effect is characterized by a reduction achieved three hours after treatment with a product. To compensate for external effects, these reductions from surgical handrub or surgical handwashing procedures are individually compared with the corresponding reductions of a reference surgical handrub performed in parallel on the same volunteers.

Our organization also provides surgical hand disinfection testing services between chemical disinfectants and antiseptics within the scope of EN 12791 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.