DS/EN 14561:2006

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)


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 standard specifies a test method and the minimum requirements for bactericidal 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.
This standard applies to products that are used in the medical area for disinfecting instruments by immersion – even if they are not covered by the EEC/93/42 Directive on Medical Devices.
This standard 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 – This method corresponds to a phase 2, step 2 test (see Annex E)."

Number of pages: 40

Published: 2006-09-27

Date of approval: 2006-06-22

International relationships : EN 14561:2006 IDT

ICS: 11.080.20 - Disinfectants and antiseptics

Item number: 51245


Committees

Committee

  • CEN/TC 216/WG 1

Danish committee

DS/S-342