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SFS-EN 13727 + A2:en

Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity in the medical area. Test method and requirements (phase 2, step 1)

Tuote ladattavissa heti Toimitusaika on noin 1 - 2 työpäivää Toimitusaika on 3 - 5 työpäivää.
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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 - 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 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 or 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 may occur in the workplace and in the home. It may 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.
NOTE 3 This method cannot be used to evaluate the activity of products against Legionella in watersystems and against mycobacteria.
EN 14885 specifies in detail the relationship of the various tests to one another and to 'use recommendations'.


Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sidokset
Velvoittavat viittaukset
EN 12353:2013 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
EN 12353:2021 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
EN 14885:2018 Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
Direktiivi
93/42/EEC Lääkinnälliset laitteet

http://ec.europa.eu »
Vahvistuspäivä
20.11.2015
Julkaisupäivä
01.12.2015
Painos
4
Sivumäärä
46
Julkaisun kieli
englanti

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