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”.<\/p>\n
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| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 3 Terms and definitions 4 Requirements for virucidal activity on surfaces <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | 5 Test methods 5.1 Principle 5.2 Materials and reagents, including cell cultures 5.2.1 Test organisms <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 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) <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 5.2.2.9 Defibrinated sheep blood <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 5.3.2 Usual microbiological laboratory equipment 5.3.2.1 Apparatus for sterilization (moist and dry heat) <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5.5 Procedure for assessing the virucidal activity of the product 5.5.1 Experimental conditions <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.5.2 Test procedure <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 5.5.3 Cytotoxicity caused by product solutions 5.5.3.1 Cytotoxic effect 5.5.3.2 Interference control \u2013 control of cell susceptibility <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 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 \u2013 PFU) 5.6.2.1 General 5.6.2.2 Calculation of TCID50 5.6.2.3 Calculation of PFU <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.9 Test report <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Annex A (informative)Examples of viruses sorted according to their presence in the human body in case of virus infection <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | Annex B (normative)Detoxification of test mixtures by molecular sieving <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Annex C (informative)Calculation of the viral infectivity titre <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" 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)<\/b><\/p>\n |