BS EN 16777:2018
$167.15
Chemical disinfectants and antiseptics. Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area. Test method and requirements (phase 2/step 2)
| Published By | Publication Date | Number of Pages |
| BSI | 2018 | 40 |
This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectants 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 non-porous surfaces including surfaces of medical devices without mechanical action. 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 on viruses in 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 |
| 9 | 3 Terms and definitions 4 Requirements for virucidal activity on surfaces |
| 10 | 5 Test methods 5.1 Principle 5.2 Materials and reagents, including cell cultures 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) |
| 12 | 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 5.2.2.8 Interfering substance |
| 13 | 5.2.2.9 Defibrinated sheep blood |
| 14 | 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 5.3 Apparatus and glassware 5.3.1 General |
| 15 | 5.3.2 Usual microbiological laboratory equipment 5.3.2.1 Apparatus for sterilization (moist and dry heat) |
| 16 | 5.3.3 Test surfaces 5.4 Preparation of test organism suspensions and product test solutions 5.4.1 Test organisms suspensions (test virus suspension) 5.4.2 Product test solution |
| 17 | 5.5 Procedure for assessing the virucidal activity of the product 5.5.1 Experimental conditions |
| 18 | 5.5.2 Test procedure |
| 19 | 5.5.3 Cytotoxicity caused by product solutions 5.5.3.1 Cytotoxic effect 5.5.3.2 Interference control – control of cell susceptibility |
| 20 | 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 |
| 21 | 5.5.4.2 Filtration technique 5.5.5 Reference test for virus inactivation 5.5.6 Titration of the virus control 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 |
| 22 | 5.7 Verification of the methodology 5.8 Expression of results 5.8.1 General 5.8.2 Calculation of the virucidal activity of products |
| 23 | 5.9 Test report |
| 25 | Annex A (informative)Examples of viruses sorted according to their presence in the human body in case of virus infection |
| 27 | Annex B (normative)Detoxification of test mixtures by molecular sieving |
| 32 | Annex C (informative)Calculation of the viral infectivity titre |
