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BS EN 17387:2021

BS EN 17387:2021

$167.15

Chemical disinfectants and antiseptics. Quantitative test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the medical area on non-porous surfaces without mechanical action. Test method and requirements (phase 2, step 2)

Published By Publication Date Number of Pages
BSI 2021 42
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This document specifies a test method and the minimum requirements for bactericidal and yeasticidal and additionally fungicidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water ā€“ or in the case of ready-to-use products ā€“ with water.

NOTE

Dilutions are necessary as three concentrations in the active to non-active range are tested.

This document applies to products that are used in the medical area for disinfecting non-porous surfaces without mechanical action.

This document applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example:

  1. in hospitals, in community medical facilities and in dental institutions;

  2. in clinics of schools, of kindergartens and of nursing homes; and can occur in the workplace and in the home. It can 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.

Using this document, it is possible to determine the activity of products like commercial formulations or active substances on bacteria and/or fungi in the conditions in which they are used and therefore it corresponds to a phase 2, step 2 test.

This method excludes the evaluation of the activity of products against mycobacteria and bacterial spores.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 1 Scope
2 Normative references
3 Terms, definitions and abbreviations
3.1 Terms and definitions
8 3.2 Symbols and abbreviations
4 Requirements
9 5 Test methods
5.1 Principle
10 5.2 Materials and reagents
5.2.1 Test organisms
5.2.2 Culture media and reagents
5.2.2.1 General
11 5.2.2.2 Water
5.2.2.3 Tryptone soya agar (TSA)
5.2.2.4 Malt extract agar (MEA)
5.2.2.5 Diluent
12 5.2.2.6 Neutralizer
5.2.2.7 Hard water for dilution of products
5.2.2.8 Interfering substance
13 5.2.3 Test surface
14 5.3 Apparatus and glassware
5.3.1 General
5.3.2 Usual microbiological laboratory equipment and, in particular, the following:
5.3.2.1 Apparatus for sterilization (moist and dry heat)
5.3.2.2 Temperature controlled cabinet or chamber capable of being controlled at test temperatures (Īø Ā± 1) Ā°C (for test temperatures others than room temperature (21,5 Ā± 3,5) Ā°C).
5.3.2.3 Water baths, capable of being controlled at (20 Ā± 1) Ā°C, at (45 Ā± 1) Ā°C and at additional test temperatures (Īø Ā± 1) Ā°C (5.5.1).
5.3.2.4 Incubator (for bactericidal activity), capable of being controlled either at (36 Ā± 1) Ā°C or (37 Ā± 1) Ā°C. An incubator at (37 Ā± 1) Ā°C may be used if an incubator at (36 Ā± 1) Ā°C is not available. The same temperature shall be used for incubations performed during a test and its control and validation.
5.3.2.5 Incubator (for fungicidal or yeasticidal activity), capable of being controlled at (30 Ā± 1) Ā°C.
5.3.2.6 pH-meter, having an inaccuracy of calibration of no more than Ā± 0,1 pH units at (20 Ā± 1) Ā°C.
5.3.2.7 Stopwatch
5.3.2.8 Shakers
15 5.3.2.9 Containers: Test tubes, culture bottles or flasks of suitable capacity.
5.3.2.10 Graduated pipettes of nominal capacities 10 ml, 1 ml, 0,1 ml, 0,05 ml and 0,001 ml, or calibrated automatic pipettes.
5.3.2.11 Petri dishes of size 90 mm to 100 mm.
5.3.2.12 Glass beads (Diameter: ā‰¤ 5 mm).
5.3.2.13 Volumetric flasks
5.3.2.14 Centrifuge (800 gN).
5.3.2.15 Refrigerator capable of being controlled at (5 Ā± 3) Ā°C.
5.3.2.16 Forceps
5.3.2.17 Microbiological filtered laminar air flow cabinet
5.3.2.18 Fritted filter: Porosity of 40 Āµm to 100 Āµm (ISO 4793, [3]).
5.3.2.19 Membrane filtration apparatus, constructed of a material compatible with the substances to be filtered.
5.3.2.20 Vacuum desiccator
5.3.2.21 Flasks with ventilated caps: Roux bottles or similar flasks.
5.3.2.22 Spectrophotometer or other suitable technique
5.3.2.23 Microscope
5.4 Preparation of test organism suspensions and product test solutions
5.4.1 Test organism suspensions
5.4.1.1 Preservation and Stock cultures of test organisms
16 5.4.1.2 Working culture of test organisms
17 5.4.1.3 Test suspensions
19 5.4.1.4 Preparation of bacterial and fungal test suspensions
5.4.1.5 Incubation and counting of bacterial and fungal test suspensions
20 5.4.1.6 Determination of VC-values
5.4.1.7 Calculation of N
21 5.4.2 Product test solutions
5.5 Procedure for assessing the bactericidal, yeasticidal and fungicidal activity of the product
5.5.1 Choice of experimental conditions
22 5.5.2 Test procedure
5.5.2.1 Test Nd ā€“ determination of bactericidal/yeasticidal/fungicidal concentrations
24 5.5.2.2 Water control Nc
25 5.5.2.3 Neutralizer control NC – verification of the absence of toxicity of the neutralizer
5.5.2.4 Method validation NT – dilution-neutralization validation
5.5.3 Counting of the test mixtures
26 5.6 Calculation and expression of results
5.6.1 Calculation of data
27 5.6.2 Verification of methodology
5.6.3 Expression of results
28 5.6.4 Conclusion
5.6.5 Precision
5.7 Test report
30 Annex A (informative)Corresponding referenced strains
31 Annex B (informative)Neutralizers
33 Annex C (informative)Expression of results with the dilution-neutralization method
35 Annex D (informative)Bactericidal activity on surfaces under clean conditions
37 Annex E (informative)Vacuum drying by desiccator – Instruction of use
E.1 Description
E.2 Procedure
38 E.3 Other types of desiccators
39 Annex F (informative)Precision of the test result

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BS EN 17387:2021
$167.15