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BS EN 17122:2019

BS EN 17122:2019

$167.15

Chemical disinfectants and antiseptics. Quantitative non- porous surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area. Test method and requirements. Phase2, step2

Published By Publication Date Number of Pages
BSI 2019 38
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This European Standard specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic 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 veterinary area on non-porous surfaces without mechanical action i.e. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry to the processing industry. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE 2 This method corresponds to a Phase 2 Step 2 test. NOTE 3 Using this European Standard, it is possible to determine the virucidal activity of the undiluted product. NOTE 4 This standard uses Porcine Parvovirus because Bovine Enterovirus Type 1 (ECBO) virus used in the suspension test EN 14675 cannot be used for surface testing because of its loss of titre during drying. Porcine Parvovirus has comparable resistance to ECBO virus.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 1 Scope
2 Normative references
3 Terms and definitions
8 4 Requirements for virucidal activity on surfaces
5 Test method
5.1 Principle
5.1.1 Outline
9 5.1.2 Test Organisms
5.1.3 Variations
5.2 Materials and reagents, including cell cultures
5.2.1 Test organisms
5.2.2 Culture media, reagents and cell cultures
5.2.2.1 General
10 5.2.2.2 Water
5.2.2.3 Phosphate buffered saline (PBS)
5.2.2.4 Neutral Red (1:1000 solution)
5.2.2.5 Foetal calf serum (FCS)
5.2.2.6 Trichloroacetic acid (10 % solution) (TCA)
5.2.2.7 Hard water for dilution of products
11 5.2.2.8 Interfering substance
5.2.2.9 Medium for cell cultures
12 5.2.2.10 Cell cultures
5.3 Apparatus and glassware
5.3.1 General
5.3.2 Usual microbiological laboratory equipment
13 5.3.3 Test surface
14 5.4 Preparation of test organism suspensions and product test solutions
5.4.1 Test organism suspensions (test virus suspension)
5.4.2 Product test solution
15 5.5 Procedure for assessing the virucidal activity of the product
5.5.1 Experimental conditions
5.5.2 Test procedure
17 5.5.3 Cytotoxicity caused by product solutions
5.5.3.1 Cytotoxic effect
5.5.3.2 Interference control ā€“ control of cell susceptibility
18 5.5.3.3 Elimination of cytotoxicity
5.5.4 Control of efficiency for suppression of disinfectant virucidal activity
5.5.4.1 Dilution in ice-cold medium
5.5.4.2 Filtration technique
5.5.5 Titration of the virus control
19 5.6 Experimental data and calculation
5.6.1 Protocol of the results
5.6.2 Calculation of infectivity titre (TCID50 ā€“ PFU)
5.6.2.1 General
5.6.2.2 Calculation of TCID50
5.6.2.3 Calculation of PFU
5.7 Verification of the methodology
20 5.8 Expression of results
5.8.1 General
5.8.2 Calculation of the virucidal activity of products
5.9 Test report
22 Annex A (informative)Referenced strains of national collections
23 Annex B (informative)
B.1 Molecular sieving with SephadexTM LH 20
B.1.1 Principle
B.1.2 SephadexTM suspension
B.1.3 Procedure
25 B.2 Molecular sieving using MicroSpinTM S 400 HR
26 Annex C (informative)Calculation of virus infectivity titre
C.1 Quantal tests – Example of TCID50 determination by the Spaerman-KƤrber method
27 C.2 Plaque test
C.3 Biometrical evaluation of experimental approaches and assessment of the disinfecting effect on the virus (reduction [R]):
C.3.1 General
28 C.3.2 Calculating the virus titre with 95 % confidence interval – Example
C.3.3 Calculating the reduction and its 95 % confidence interval
29 C.3.4 Calculating the average reduction (R(mi)) and its 95 % confidence interval
30 C.3.5 Practical example
33 Annex D (informative)Example of a typical test report
35 Annex E (informative)Full virucidal activity and activity against enveloped viruses only

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BS EN 17122:2019
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