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EN 13727:2012 Standard

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  Keywords:

#products #european #disinfection #standard #may

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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)

  Purpose

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.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 13727:2003"

Anyway is still possible use the "EN 13727:2003" until November 30th, 2012

  Related Standards

EN 60601-2-25:1995/A1:1999

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographsIEC 60601-2-25:1993

EN ISO 10993-17:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

EN ISO 11810-2:2009

Medical devices Directive (93/42/EEC)

Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-pro...

EN ISO 11810-1:2009

Medical devices Directive (93/42/EEC)

Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient pro...

EN ISO 11737-1:2006/AC:2009

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

EN ISO 11737-1:2006

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

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