BS EN 14563:2008
Current
The latest, up-to-date edition.
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)
Hardcopy , PDF
English
31-12-2008
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
mycobactericidal/tuberculocidal 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) - Examples of neutralizers of the
residual antimicrobial activity
of chemical disinfectants and
antiseptics and rinsing liquids
Annex C (informative) - Graphical representations of
the test method
Annex D (informative) - Example of a typical test report
Annex ZA (informative) - Relationship between this European
Standard and the Essential
Requirements of EU Directive 93/42/EEC
Bibliography
Describes 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.
Committee |
CH/216
|
DevelopmentNote |
Supersedes 02/564188 DC. (12/2008)
|
DocumentType |
Standard
|
Pages |
40
|
PublisherName |
British Standards Institution
|
Status |
Current
|
Supersedes |
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.
EN14885 specifies in detail the relationship of the various tests to one another and to \'use recommendations\'.
NOTE This method corresponds to a phase 2, step2 test.
Standards | Relationship |
EN 14563:2008 | 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 14820:2004 | Single-use containers for human venous blood specimen collection |
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