DS/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)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.64
Legislation:

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

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 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 (see Annex E).

Number of pages: 40

Published: 2005-04-23

Date of approval: 2005-03-17

International relationships : EN 14348:2005 IDT

ICS: 11.080.20 - Disinfectants and antiseptics

Item number: 49175


Committees

Committee

  • CEN/TC 216

Danish committee

DS/S-342