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BS EN 14563:2008

Current
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)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-31-2008

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.

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.

Committee
CH/216
DevelopmentNote
Supersedes 02/564188 DC. (12/2008)
DocumentType
Standard
Pages
40
PublisherName
British Standards Institution
Status
Current
Supersedes

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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