Overview

This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water (or for ready-to-use products with water). Products can only be tested at a concentration of 80 % or less (or 97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance. This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding and other means. This European Standard applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example in hospitals, in community medical facilities and in dental institutions; in clinics of schools, of kindergartens and of nursing homes; and they can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients. The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. This method corresponds to a phase 2 step 1 test. This method cannot be used to evaluate the activity of products against Legionella in water systems against mycobacteria and against bacterial spores. EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations". Compared with DIN EN 13727:2012-07, the following changes have been made: a) a neutralization time of 10 s for all products with contact times of 10 min or shorter has been added to the list of changes in the foreword; b) Former Yugoslav Republic of Macedonia and Turkey have been added to the list of countries in the foreword; c) in 5.4.2, 5.5.4.1 and 5.6.2.3, the procedures for testing ready-to-use products have been reviewed or supplemented; d) in 5.6.2.2, the volume for membrane filtration and/or hand wash products have been added; e) in 5.6.2.4, equation errors have been corrected in examples a1 and a2; f) in 5.8.2, the term "hygienic" has been added twice; g) in 5.9.2, lg reduction for surgical handwash has been corrected from 3 to 5. The committee responsible for this standard is NA 063-04-07 AA "Chemische Desinfektionsmittel und Antiseptika in der Humanmedizin" ("Chemical disinfectants and antiseptics in human medicine") at DIN.

Document: references other documents

Responsible national committee

NA 176-03-06 AA - Chemical disinfectants and antiseptics in human medicine  

Responsible european committee

CEN/TC 216/WG 1 - Human medicine