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BSI 22/30460212 DC:2022 Edition

BSI 22/30460212 DC:2022 Edition

$13.70

BS EN 16615. Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity on non-porous surfaces with mechanical action employing wipes or mops in the medical area (4- field test) – Test method and requirements (phase 2, step 2)

Published By Publication Date Number of Pages
BSI 2022 55
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PDF Catalog

PDF Pages PDF Title
7 1 Scope
8 2 Normative references
3 Terms and definitions
4 Requirements
9 5 Test methods
5.1 Principle
10 5.2 Materials and reagents
5.2.1 Test organism
11 5.2.2 Culture media and reagents
5.2.2.1 General
5.2.2.2 Water
5.2.2.3 Medium
13 5.2.2.4 Diluent
5.2.2.5 Neutralizer
5.2.2.6 Sterile defibrinated sheep blood
5.2.2.7 Hard water for dilution of products
14 5.2.2.8 Interfering substances
15 5.3 Apparatus and glassware
19 5.4 Preparation of test organism suspensions and product test solutions
5.4.1 Test organism suspensions
5.4.1.1 General
5.4.1.2 Preservation and stock cultures of test organisms
5.4.1.3 Working culture of test organisms
20 5.4.1.4 Test suspension (N)
23 5.4.1.5 Validation suspension (NV)
24 5.4.1.6 Incubation and counting of the test suspensions
5.4.2 Product test solution
25 5.5 Procedure for assessing the bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity of the product
5.5.1 General
5.5.1.1 Experimental conditions
26 5.5.1.2 Selection of neutralizer
5.5.1.3 General instruction for validation and control procedures
5.5.1.4 Equilibration of temperature
27 5.5.1.5 Precautions for manipulation of test organisms
5.5.1.6 Inoculation of the test-surface
5.5.2 Method
5.5.2.1 General
28 5.5.2.2 Test Na (Determination of bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobacericidal concentrations), water control NW
29 5.5.2.3 Neutralizer control B – verification of the absence of toxicity of the neutralizer
5.5.2.4 Method validation C – dilution-neutralization validation
30 5.5.2.5 Incubation and counting of the test mixture
5.6 Experimental data and calculation
5.6.1 Explanation of terms and abbreviations
5.6.1.1 Overview of the different suspensions and test mixtures
31 5.6.1.2 Vc-values
5.6.2 Calculation
5.6.2.1 General
5.6.2.2 Determination of Vc-values
32 5.6.2.3 Calculation of N
5.6.2.4 Calculation of Na, NW, Dc0, Dct
35 5.6.2.5 Calculation of NV and NV0
36 5.6.2.6 Calculation of B and C
5.7 Verification of methodology
5.7.1 General
5.7.2 Control of weighted mean counts
37 5.7.3 Basic limits
5.8 Expression of results and precision
5.8.1 Overview of the different suspensions/test mixtures
38 5.8.2 Vc-values
5.8.3 Limiting test organism and bactericidal and yeasticidal concentration
5.8.3.1 Bactericidal concentration
39 5.8.3.2 Yeasticidal concentration
5.8.3.3 Tuberculocidal concentration
5.8.3.4 Mycobactericidal concentration
5.8.4 Precision, repetitions
40 5.9 Interpretation of results – conclusion
41 5.10 Test report
43 Annex A (informative)Referenced strains in national collections
44 Annex B (informative)Neutralizers
45 Annex C (informative)Graphical representations of the test method
48 Annex D (informative)Example of a typical test report
52 Annex E (informative)Alternative drying endpoint
54 Annex F (informative)Additional test temperature

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BSI 22/30460212 DC
$13.70