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)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-30-2006

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test method
  5.1 Principle
  5.2 Materials and reagents
  5.3 Apparatus and glassware
  5.4 Preparation of test organism suspensions and product
       test solutions
  5.5 Procedure for assessing the bactericidal activity of
       the product
  5.6 Experimental data and calculation
  5.7 Verification of methodology
  5.8 Expression of results and precision
  5.9 Interpretation of results - conclusion
  5.10 Test report
Annex A (informative) Referenced strains in national collections
Annex B (informative) Suitable neutralizers
Annex C (informative) Graphical representations of the test method
Annex D (informative) Example of a typical test report
Annex E (informative) Information on the application and interpretation
                       of European Standards on chemical disinfectants
                       and antiseptics
Annex ZA (informative) Relationship between this European Standard
                       and the Essential Requirements of EU Directive
                       93/42/EEC
Bibliography

Defines 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 European 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 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, 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, step2 test (see AnnexE).

Committee	CH/216
DevelopmentNote	Supersedes 02/564186 DC (06/2006)
DocumentType	Standard
Pages	40
PublisherName	British Standards Institution
Status	Current
Supersedes	02/564186 DC : DRAFT OCT 2002

Standards	Relationship
NBN EN 14561 : 2006	Identical
SN EN 14561 : 2006	Identical
NF EN 14561 : 2007	Identical
UNI EN 14561 : 2006	Identical
NS EN 14561 : 1ED 2006	Identical
I.S. EN 14561:2006	Identical
EN 14561 : 2006	Identical
NEN EN 14561 : 2006	Identical
UNE-EN 14561:2007	Identical
DIN EN 14561 E : 2006	Identical
DIN EN 14561:2006-08	Identical

EN 12353:2013	Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
EN 13727:2012+A2:2015	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
EN 14820:2004	Single-use containers for human venous blood specimen collection

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BS EN 14561:2006

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

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