BS EN 14476:2013+A2:2019
$189.07
Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (Phase 2/Step 1)
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 46 |
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, i. e, products that are not diluted when applied, with water. Products can only be tested at a concentration of 80 % (97 %, with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance. This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection. This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: – in hospitals, in community medical facilities, and in dental institutions; – in clinics of schools, of kindergartens, and of nursing homes; and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients. 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. NOTE 3 EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 9 | 1 Scope 2 Normative references 3 Terms and definitions |
| 10 | 4 Requirements |
| 12 | 5 Test methods 5.1 Principle 5.2 Materials and reagents, including cell cultures 5.2.1 Test organisms |
| 13 | 5.2.2 Culture media, reagents and cell cultures 5.2.2.1 General 5.2.2.2 Water |
| 14 | 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 |
| 15 | 5.2.2.8 Interfering substance |
| 16 | 5.2.2.9 Defibrinated sheep blood 5.2.2.10 Medium for cell cultures 5.2.2.11 Cell cultures 5.3 Apparatus and glassware |
| 17 | 5.4 Preparation of test organism suspensions and product test solutions 5.4.1 Test organisms suspensions (test virus suspension) |
| 18 | 5.4.2 Product test solutions 5.5 Procedure for assessing the virucidal activity of the product 5.5.1 General 5.5.1.1 Experimental conditions |
| 19 | 5.5.1.2 Preparation 5.5.1.3 Special instruction for ready-to-use products 5.5.1.4 Equilibration of temperature 5.5.2 Test procedure |
| 20 | 5.5.3 Modified method for ready-to-use products |
| 21 | 5.5.4 Cytotoxicity caused by product test solutions 5.5.4.1 Cytotoxic effect 5.5.4.2 Interference control – control of cell susceptibility 5.5.4.3 Elimination of cytotoxicity |
| 22 | 5.5.5 Control of efficiency of suppression of product’s activity 5.5.5.1 Dilution in ice-cold medium 5.5.5.2 Filtration technique 5.5.6 Reference test for virus inactivation 5.5.6.1 General |
| 23 | 5.5.6.2 Cytotoxicity control of the formaldehyde test solution 5.5.7 Titration of the virus control 5.5.8 Titration of test samples 5.6 Experimental data and calculation 5.6.1 Protocol of results 5.6.2 Calculation of infectivity titer (TCID50 or 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 |
| 24 | 5.8 Expression of results 5.8.1 General 5.8.2 Calculation of the virucidal activity of products 5.9 Test report |
| 27 | Annex A (informative)Examples of viruses sorted according to their presence in the human body in case of virus infection |
| 29 | Annex B (informative)Detoxification of test mixtures by molecular sieving B.1 Molecular sieving with SephadexTM LH 20) B.1.1 Principle B.1.2 Sephadex suspension B.1.3 Procedure |
| 31 | B.2 Molecular sieving using MicroSpinTM S 400 HR |
| 34 | Annex C (informative)Calculation of the viral infectivity titre C.1 Quantal tests — Example of TCID50 determination by the Spearman-Kärber method |
| 35 | 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 |
| 36 | C.3.2 Calculating the virus titre with 95 % confidence interval C.3.3 Calculating the reduction and its 95 % confidence interval |
| 37 | C.3.4 Calculating the average reduction (R(mi)) and its 95 % confidence interval. |
| 38 | C.3.5 Practical example C.3.5.1 Calculating the virus titre with 95 % confidence interval: |
| 39 | C.3.5.2 Calculating the reduction and its 95 % confidence interval: C.3.5.3 Calculating the average reduction [R(mi)] and its 95 % confidence interval: |
| 40 | Annex D (informative)Presentation of test results of one active concentration |
| 43 | Annex E (informative)Quantitative determination of formaldehyde concentrations |
| 44 | Annex ZA(informative)!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC |
