BS EN 17111:2018
$167.15
Chemical disinfectants and antiseptics. Quantitative carrier test for the evaluation of virucidal activity for instruments used in the medical area. Test method and requirements (phase 2, step 2)
| Published By | Publication Date | Number of Pages |
| BSI | 2018 | 44 |
This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant 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 document applies to products that are used in the medical area for disinfecting instruments by immersion. This document 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 2 test. 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 |
| 8 | 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements |
| 10 | 5 Test method 5.1 Principle 5.2 Materials and reagents 5.2.1 Test organisms |
| 11 | 5.2.2 Culture media, reagents and cell cultures 5.2.2.1 General 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) |
| 12 | 5.2.2.6 Trichloroacetic acid (10 % w/V solution) (TCA) 5.2.2.7 Hard water for dilution of products 5.2.2.8 Interfering substance |
| 13 | 5.2.2.9 Defibrinated sheep blood 5.2.2.10 Medium for cell cultures 5.2.2.11 Cell cultures 5.2.2.12 Reference glutardialdehyde (Glutaral, 1,5-Pentanedial) CAS Number 111-30-8 |
| 14 | 5.3 Apparatus and glassware 5.3.1 General 5.3.2 Usual microbiological laboratory equipment) |
| 16 | 5.4 Preparation of test organism suspensions and product test solutions 5.4.1 Test organism suspensions (test suspension) 5.4.2 Product test solution |
| 17 | 5.5 Procedure for assessing the virucidal activity of the product 5.5.1 General 5.5.1.1 Experimental conditions (minimum and additional) 5.5.1.2 General instructions for validation and control procedures 5.5.1.3 Equilibration of temperature |
| 18 | 5.5.1.4 Precautions for manipulation of test organisms 5.5.1.5 Inoculation of the carriers 5.5.2 Method 5.5.2.1 Test “Na” (Determination of virucidal concentrations), water control “NW” |
| 19 | 5.5.2.2 Quantal tests (end point titration) – [the procedures 1) to 2) are alternatives] 5.5.2.3 Plaque assay |
| 20 | 5.5.3 Cytotoxicity caused by product solutions 5.5.3.1 Cytotoxic effect 5.5.3.2 Interference control – control of cell susceptibility 5.5.3.3 Elimination of cytotoxicity |
| 21 | 5.5.4 Control of efficiency for suppression of disinfectant activity 5.5.4.1 Dilution in ice-cold medium 5.5.4.2 Filtration technique 5.5.5 Reference test for virus inactivation 5.5.6 Titration of the virus control 5.5.7 Titration of test samples |
| 22 | 5.6 Experimental data and calculation 5.6.1 Protocol of the results 5.6.2 Calculation of infectivity titre (TCID50 – 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 |
| 23 | 5.8 Explanation of terms and abbreviations 5.9 Expression of results 5.9.1 General 5.9.2 Calculation of the virucidal activity of products 5.10 Calculation 5.10.1 Virucidal activity 5.10.1.1 Virucidal activity for general purposes 5.10.1.2 Virucidal activity for specific purposes |
| 24 | 5.10.2 Claims 5.11 Test report |
| 26 | Annex A (informative)Example of a typical test report |
| 28 | Annex B (informative)Examples of viruses sorted according to their presence in the human body in case of virus infection |
| 30 | Annex C (normative)Detoxification of test mixtures by molecular sieving C.1 Molecular sieving with Sephadex™ LH 20) C.1.1 Principle C.1.2 Sephadex suspension C.1.3 Procedure |
| 32 | C.2 Molecular sieving using MicroSpin™ S 400 HR C.3 Determination of the residual virus titre by the large-volume-plating (LVP) method C.3.1 General |
| 33 | C.3.2 Example for the calculation of titres and the reduction according to the large-volume-plating Method |
| 35 | Annex D (informative)Calculation of the viral infectivity titre D.1 Quantal tests – Example of TCID50 determination by the Spaerman-Kärber method |
| 36 | D.2 Plaque test D.3 Biometrical evaluation of experimental approaches and assessment of the disinfecting effect on the virus (reduction [R]): D.3.1 General |
| 37 | D.3.2 Calculating the virus titre with 95 % confidence interval D.3.3 Calculating the reduction and its 95 % confidence interval |
| 38 | D.3.4 Calculating the average reduction (R(mi)) and its 95 % confidence interval |
| 39 | D.3.5 Practical example |
