EN 14348:2005

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)

Publication date:   Aug 30, 2005

General information

90.93 Standard confirmed   Nov 6, 2009

CEN

CEN/TC 216 Chemical disinfectants and antiseptics

European Norm

11.080.20   Disinfectants and antiseptics

Buying

Published

Language in which you want to receive the document.

Scope

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.
This document applies to products that are used in the medical area including those that are covered by the EEC/93/42 Directive on Medical Devices.
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 kindergardens 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 (see Annex E).

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

PUBLISHED
EN 14348:2005
90.93 Standard confirmed
Nov 6, 2009