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BS EN 17387:2021 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 m, 2021
- undefined
- 1 Scope
- 2 Normative references
- 3 Terms, definitions and abbreviations [Go to Page]
- 3.1 Terms and definitions
- 3.2 Symbols and abbreviations
- 4 Requirements
- 5 Test methods [Go to Page]
- 5.1 Principle
- 5.2 Materials and reagents [Go to Page]
- 5.2.1 Test organisms
- 5.2.2 Culture media and reagents [Go to Page]
- 5.2.2.1 General
- 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
- 5.2.2.6 Neutralizer
- 5.2.2.7 Hard water for dilution of products
- 5.2.2.8 Interfering substance
- 5.2.3 Test surface
- 5.3 Apparatus and glassware [Go to Page]
- 5.3.1 General
- 5.3.2 Usual microbiological laboratory equipment and, in particular, the following: [Go to Page]
- 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 (θ ± 1) °C (for test temperatures others than room temperature (21,5 ± 3,5) °C).
- 5.3.2.3 Water baths, capable of being controlled at (20 ± 1) °C, at (45 ± 1) °C and at additional test temperatures (θ ± 1) °C (5.5.1).
- 5.3.2.4 Incubator (for bactericidal activity), capable of being controlled either at (36 ± 1) °C or (37 ± 1) °C. An incubator at (37 ± 1) °C may be used if an incubator at (36 ± 1) °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 ± 1) °C.
- 5.3.2.6 pH-meter, having an inaccuracy of calibration of no more than ± 0,1 pH units at (20 ± 1) °C.
- 5.3.2.7 Stopwatch
- 5.3.2.8 Shakers
- 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: ≤ 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 ± 3) °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 µm to 100 µm (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 [Go to Page]
- 5.4.1 Test organism suspensions [Go to Page]
- 5.4.1.1 Preservation and Stock cultures of test organisms
- 5.4.1.2 Working culture of test organisms
- 5.4.1.3 Test suspensions
- 5.4.1.4 Preparation of bacterial and fungal test suspensions
- 5.4.1.5 Incubation and counting of bacterial and fungal test suspensions
- 5.4.1.6 Determination of VC-values
- 5.4.1.7 Calculation of N
- 5.4.2 Product test solutions
- 5.5 Procedure for assessing the bactericidal, yeasticidal and fungicidal activity of the product [Go to Page]
- 5.5.1 Choice of experimental conditions
- 5.5.2 Test procedure [Go to Page]
- 5.5.2.1 Test Nd – determination of bactericidal/yeasticidal/fungicidal concentrations
- 5.5.2.2 Water control Nc
- 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
- 5.6 Calculation and expression of results [Go to Page]
- 5.6.1 Calculation of data
- 5.6.2 Verification of methodology
- 5.6.3 Expression of results
- 5.6.4 Conclusion
- 5.6.5 Precision
- 5.7 Test report
- Annex A (informative)Corresponding referenced strains
- Annex B (informative)Neutralizers
- Annex C (informative)Expression of results with the dilution-neutralization method
- Annex D (informative)Bactericidal activity on surfaces under clean conditions
- Annex E (informative)Vacuum drying by desiccator - Instruction of use [Go to Page]
- E.1 Description
- E.2 Procedure
- E.3 Other types of desiccators
- Annex F (informative)Precision of the test result [Go to Page]
