DS/EN 14563:2008

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments 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 European Standard 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.
This European 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 European 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, kindergartens and 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.
EN 14885 specifies in detail the relationship of the various tests to one another and to ""use recommendations"".
NOTE – This method corresponds to a phase 2, step 2 test.

Number of pages: 40

Published: 2009-05-18

Date of approval: 2009-01-13

International relationships : EN 14563:2008 IDT

ICS: 11.080.20 - Disinfectants and antiseptics

Item number: 51249


Committees

Committee

  • CEN/TC 216/WG 1

Danish committee

DS/S-342