This European Standard specifies a test method and the minimum requirements for the microbicidal activity of a defined disinfection process for the treatment of contaminated linen. This procedure is carried out by using a washing machine as defined in Chapter 5.3.2.17 and refers to the disinfection step without prewash. This European Standard applies to areas and situations where disinfection is indicated. Such indications occur in patient care, for example: – in hospitals, in community medical facilities and in dental institutions; – in schools, kindergartens and nursing homes; – institutions where patients are accommodated, which could suffer from transmissible diseases; – other applications where hygienic treatment of linen is necessary (e.g. food processing, hotels, workwear e. g. from the pharmaceutical industry, laboratories, foodstuffs area or similar institutions). The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE This method corresponds to a phase 2 step 2 test (Annex F).<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 4<\/td>\n | Contents Page <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | 4 Requirements <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 5 Test methods 5.1 Principle 5.2 Materials and reagents 5.2.1 Test organisms <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | 5.2.2 Culture media and reagents 5.2.2.1 General 5.2.2.2 Water used for preparation of media 5.2.2.3 Hard water for dilution of products for validation tests <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 5.2.2.4 Tryptone Soy Agar (TSA) 5.2.2.5 Tryptone Soy Broth (TSB) 5.2.2.6 Brain Heart Infusion Agar (BHI) <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 5.2.2.7 Malt Extract Agar (MEA) 5.2.2.8 Middlebrook and Cohn 7H10 medium incl. 10\u00a0% OADC (7H10) 5.2.2.9 Diluent 5.2.2.10 Neutralizer 5.2.2.11 Sterile defibrinated sheep blood 5.3 Apparatus and glassware 5.3.1 General <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 5.3.2 Usual microbiological laboratory equipment) <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 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 and test organisms <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5.4.1.4 Test suspension (N) <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 5.4.1.5 Inoculation of the carriers 5.4.2 Product test solutions for validation tests 5.5 Procedure for assessing the microbicidal activity of the product 5.5.1 General 5.5.1.1 Experimental conditions (obligatory and additional) <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 5.5.1.2 Choice of neutralizer 5.5.1.3 General instructions for validation and control procedures 5.5.1.4 Equilibration of temperature for validation tests 5.5.1.5 Precautions for manipulation of test organisms <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.5.2 Method) 5.5.2.1 General 5.5.2.2 Test ‘Na’ (Determination of microbicidal concentrations) and reference ‘N0’ (Microbial content on carriers) <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 5.5.2.3 Reference control \u2018NW\u2019 (Test without detergent or disinfectant) 5.5.2.4 Reference control \u2018RI\u2019 (Non contaminated cotton carrier in the test procedure) 5.5.2.5 Reference control \u2018RII\u2019 (Test with detergent only) 5.5.2.6 Validation suspension (NV, NVB) 5.5.2.7 Neutralizer control \u2018B\u2019 \u2013 verification of the absence of toxicity of the neutralizer <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 5.5.2.8 Method validation \u2018C\u2019 \u2013 dilution-neutralization validation 5.5.2.9 Incubation and counting of the test and the validation suspensions <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 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 \ufeffVC-values 5.6.2 Calculation 5.6.2.1 General 5.6.2.2 Determination of VC-values <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 5.6.2.3 Calculation of N and N0 (N0 is not described) 5.6.2.4 Calculation of Na <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 5.6.2.5 Calculation of NV and NVB 5.6.2.6 Calculation of NW, RI, RII, B and C 5.7 Verification of methodology 5.7.1 General 5.7.2 Control of weighted mean counts <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 5.7.3 Basic limits 5.8 Expression of results and precision 5.8.1 Reduction <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 5.8.2 Repetitions 5.9 Interpretation of results \u2013 conclusion 5.9.1 General 5.9.2 Microbicidal activity 5.9.2.1 Processes at temperatures\u00a0<\u00a060\u00b0C <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 5.9.2.2 Processes at temperatures\u00a0\u2265\u00a060\u00b0C 5.10 Test report <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Annex\u00a0A (informative)Referenced strains in national collections <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Annex\u00a0B (informative)Suitable neutralizers and rinsing liquids B.1 General B.2 Neutralizers <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | B.3 Neutralizer added to the agar for counting <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | Annex\u00a0C (informative)Graphical representations of the test method <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Annex\u00a0ZA (informative)Relationship between this European Standard and the Essential Requirements of EU\u00a0Directive 93\/42\/EEC concerning medical devices <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Chemical disinfectants and antiseptics. Chemical-thermal textile disinfection. Test method and requirements (phase 2, step 2)<\/b><\/p>\n |