SS-EN-13727 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)

SS-EN-13727 - 2012/A2 EDITION - CURRENT
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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 against mycobacteria and against bacterial spores. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

To find similar documents by classification:

11.080.20 (Disinfectants and antiseptics Chemicals for industrial and domestic disinfection purposes, see 71.100.35)


Medical devices

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Designation Name

SS-EN 13727:2012+A2:2015

Revision Level

2012/A2 EDITION

Status

Current

Publication Date

Nov. 2, 2015

Language(s)

English

Page Count

64

International Equivalent

EN 13727:2012+A2:2015(IDT)