Chemické dezinfekční přípravky a antiseptika

Komise : CEN/TC 216 (Chemical disinfectants and antiseptics)
Původce: CEN
K připomínkám do: 24.09.2019
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This document specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water, or – in the case of ready-to-use products – with water. Products can only be tested at a concentration of 80 % or less (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.

This document 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 or other means.

This document 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 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.

NOTE 1       The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.

NOTE 2       This method corresponds to a phase 2 step 1 test.

EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

Komise : CEN/TC 216 (Chemical disinfectants and antiseptics)
Původce: CEN
K připomínkám do: 14.10.2019
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This document specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of virus contamination on hands when rubbed onto the artificially contaminated hands of volunteers.

NOTE 1        Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions.

This document applies to products for hygienic handrub for use in areas and situations where disinfection 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 kindergardens and of nursing homes;

and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patient.

EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

NOTE 2       This method corresponds to a phase 2, step 2 test.