prEN 14476

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1) prEN 14476

Publication date:   Jun 6, 2024

Scope

TThis document specifies a test method and the minimum requirements for virucidal 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, i.e, products that are not diluted when applied, - with water. Ready-to-use-products can only be tested at a concentration up to 80 % (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, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection.
This document applies to 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 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 patient.
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.
NOTE 3 EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".