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EN 14348:2005 Standard

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  Keywords:

#disinfectants #products #water #organisms #adding

  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 mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)

  Purpose

This document specifies a test method and the minimum requirements for mycobactericidal (or tuberculocidal) activity of chemical disinfectant 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 as some dilution is always produced by adding the test organisms and interfering substance.

  Publication

Friday 17th of November 2017

  Related Standards

EN ISO 13408-1:2015

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

EN ISO 10993-13:2010

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medic...

EN ISO 11140-1:2009

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

EN ISO 11138-3:2009

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization process...

EN ISO 11138-2:2009

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization pro...

EN ISO 11137-2:2015

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

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