BS EN 1276:2019 – TC:2020 Edition
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Tracked Changes. Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas. Test method and requirements (phase 2, step 1)
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 93 |
This European Standard specifies a test method and the minimum requirements for bactericidal 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. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance. This document applies to products that are used in food, industrial, domestic and institutional areas excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. The following areas are at least included: a) processing, distribution and retailing of: 1) food of animal origin: ? milk and milk products; ? meat and meat products; ? fish, seafood, and related products; ? eggs and egg products; ? animal feeds; ? etc. 2) food of vegetable origin: ? beverages; ? fruits, vegetables and derivatives (including sugar, distillery, etc.); ? flour, milling and baking; ? animal feeds; ? etc. b) institutional and domestic areas: ? catering establishments; ? public areas; ? public transports; ? schools; ? nurseries; ? shops; ? sports rooms; ? waste containers (bins, etc.); ? hotels; ? dwellings; ? clinically non sensitive areas of hospitals; ? offices; ? etc. c) other industrial areas: ? packaging material; ? biotechnology (yeast, proteins, enzymes, etc.); ? pharmaceutical; ? cosmetics and toiletries; ? textiles; ? space industry, computer industry; ? etc. 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 1 test.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 51 | undefined |
| 56 | 1 Scope |
| 57 | 2 Normative references 3 Terms and definitions |
| 58 | 4 Requirements |
| 59 | 5 Test method 5.1 Principle |
| 60 | 5.2 Materials and reagents 5.2.1 Test organisms 5.2.2 Culture media and reagents 5.2.2.1 General |
| 61 | 5.2.2.2 Water 5.2.2.3 Tryptone Soya Agar (TSA) 5.2.2.4 Diluent 5.2.2.5 Neutralizer |
| 62 | 5.2.2.6 Rinsing liquid (for membrane filtration) 5.2.2.7 Hard water for dilution of products 5.2.2.8 Interfering substance |
| 63 | 5.3 Apparatus and glassware 5.3.1 General 5.3.2 Usual microbiological laboratory equipment) and, in particular, the following |
| 64 | 5.4 Preparation of test organism suspensions and product test solutions 5.4.1 Test organism suspensions (test and validation suspension) 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 |
| 65 | 5.4.1.4 Test suspension (“N”) 5.4.1.5 Validation suspension (“Nv”) 5.4.1.6 Incubation and counting of the test and the validation suspensions |
| 66 | 5.4.2 Product test solutions 5.5 Procedure for assessing the bactericidal activity of the product 5.5.1 General 5.5.1.1 Experimental conditions |
| 67 | 5.5.1.2 Choice of test method (dilution-neutralization or membrane filtration) 5.5.1.3 General instructions for validation and control procedures 5.5.1.4 Equilibration of temperature 5.5.1.5 Precautions for manipulation of test organisms 5.5.2 Dilution-neutralization method) 5.5.2.1 General |
| 68 | 5.5.2.2 Test “Na” – determination of bactericidal concentrations 5.5.2.3 Experimental conditions control “A” – validation of the selected experimental conditions and/or verification of the absence of any lethal effect in the test conditions 5.5.2.4 Neutralizer control “B” – verification of the absence of toxicity of the neutralizer |
| 69 | 5.5.2.5 Method validation “C” – dilution-neutralization validation 5.5.2.6 Incubation and counting of the test mixture and the control and validation mixtures |
| 70 | 5.5.3 Membrane filtration method) 5.5.3.1 General 5.5.3.2 Test “Na” – determination of the bactericidal concentrations 5.5.3.3 Experimental conditions control “A” – validation of the selected experimental conditions and/or verification of the absence of any lethal effect in the test conditions |
| 71 | 5.5.3.4 Filtration control “B” – validation of the filtration procedure 5.5.3.5 Method validation “C” – validation of the membrane filtration method or counting of the bacteria on the membranes which have previously been in contact with the mixture of product and interfering substance 5.5.3.6 Incubation and counting of test mixture and the control and the validation mixtures |
| 72 | 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 5.6.1.2 Vc values 5.6.2 Calculation 5.6.2.1 General 5.6.2.2 Determination of Vc values |
| 73 | 5.6.2.3 Calculation of N and N0 |
| 74 | 5.6.2.4 Calculation of Na 5.6.2.5 Calculation of Nv and Nvo |
| 75 | 5.6.2.6 Calculation of A, B and C 5.7 Verification of methodology 5.7.1 General 5.7.2 Control of weighted mean counts 5.7.3 Basic limits |
| 76 | 5.8 Expression of results and precision 5.8.1 Reduction 5.8.2 Control of active and non-active product test solution (5.4.2) 5.8.3 Limiting test organism and bactericidal concentration 5.8.4 Precision, replicates 5.9 Interpretation of results – conclusion 5.9.1 General 5.9.2 Bactericidal activity for general purposes |
| 77 | 5.9.3 Bactericidal activity for hand hygiene 5.10 Test report |
| 79 | Annex A (informative)Referenced strains in national collections |
| 80 | Annex B (informative)Neutralizers and rinsing liquids |
| 82 | Annex C (informative)Graphical representations of dilution neutralization method and membrane filtration method C.1 Dilution-neutralization method |
| 84 | C.2 Membrane filtration method |
| 86 | Annex D (informative)Example of a typical test report |
| 90 | Annex E (informative)Precision of the test result |
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BS EN 1276:2019
Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity of chemical…
