BS EN 13624:2013
$198.66
Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area. Test method and requirements (phase 2, step 1)
| Published By | Publication Date | Number of Pages |
| BSI | 2013 | 58 |
This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal 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 — with water. Products can only be tested at a concentration of 80 % or less (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, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.
This European Standard applies to areas and situations where disinfection or antisepsis 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.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 7 | 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements |
| 9 | 5 Test method 5.1 Principle 5.2 Materials and reagents 5.2.1 Test organisms |
| 10 | 5.2.2 Culture media and reagents 5.2.2.1 General 5.2.2.2 Water 5.2.2.3 Malt extract agar (MEA) 5.2.2.4 Diluent |
| 11 | 5.2.2.5 Neutralizer 5.2.2.6 Rinsing liquid (for membrane filtration) 5.2.2.7 Hard water for dilution of products 5.2.2.8 Interfering substance 5.2.2.8.1 General |
| 12 | 5.2.2.8.2 Clean conditions (bovine albumin solution – low concentration) 5.2.2.8.3 Dirty conditions (mixture of bovine albumin solutions – high concentration with sheep erythrocytes) 5.2.2.8.4 Clean and dirty conditions for the modified method for ready-to-use products (5.5.4) 5.2.2.9 Defibrinated sheep blood 5.3 Apparatus and glassware 5.3.1 General |
| 13 | 5.3.2 Usual microbiological laboratory equipment2F ) |
| 14 | 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 of test organisms 5.4.1.3.1 Candida albicans (yeast) 5.4.1.3.2 Aspergillus brasiliensis (previously A. niger) (mould) |
| 15 | 5.4.1.3.3 Other test organisms (yeasts or moulds) 5.4.1.4 Test suspension (N) 5.4.1.4.1 Candida albicans |
| 16 | 5.4.1.4.2 Aspergillus brasiliensis |
| 17 | 5.4.1.5 Validation suspension (NV and NVB) |
| 18 | 5.4.1.6 Incubation and counting of the test and the validation suspensions 5.4.2 Product test solutions |
| 19 | 5.5 Procedure for assessing the fungicidal and yeasticidal activity of the product 5.5.1 General 5.5.1.1 Experimental conditions 5.5.1.2 Choice of test method 5.5.1.3 General instructions for validation and control procedures |
| 20 | 5.5.1.4 Equilibration of temperature 5.5.1.5 Precautions for manipulation of test organisms 5.5.2 Dilution-neutralization method5F ) 5.5.2.1 General 5.5.2.2 Test Na – determination of fungicidal or yeasticidal concentrations |
| 21 | 5.5.2.3 Experimental conditions control A – validation of the selected experimental conditions and/or verification of the absence of any lethal effect in the test conditions 5.5.2.4 Neutralizer control B – verification of the absence of toxicity of the neutralizer 5.5.2.5 Method validation C – dilution-neutralization validation |
| 22 | 5.5.2.6 Incubation and counting of the test mixture and the control and validation mixtures 5.5.3 Membrane filtration method6F ) 5.5.3.1 General 5.5.3.2 Test Na – determination of the fungicidal or yeasticidal concentrations |
| 23 | 5.5.3.3 Experimental conditions control A – validation of the selected experimental conditions and/or verification of the absence of any lethal effect in the test conditions 5.5.3.4 Filtration control B – validation of the filtration procedure 5.5.3.5 Method validation C – validation of the membrane filtration method or counting of the fungi on the membranes which have previously been in contact with the mixture of product and interfering substance |
| 24 | 5.5.3.6 Incubation and counting of test mixture and the validation mixtures 5.5.4 Modified method for ready-to-use products 5.5.4.1 General 5.5.4.2 Modified dilution-neutralization method 5.5.4.2.1 Test Na |
| 25 | 5.5.4.2.2 Experimental conditions control A – validation of the selected experimental conditions and/or verification of the absence of any lethal effect in the test conditions 5.5.4.2.3 Neutralizer control B – verification of the absence of toxicity of the neutralizer 5.5.4.2.4 Method validation C – dilution-neutralization validation 5.5.4.3 Modified membrane filtration method 5.5.4.3.1 Test Na 5.5.4.3.2 Experimental conditions control A – validation of the selected experimental conditions and/or verification of the absence of any lethal effect in the test conditions 5.5.4.3.3 Filtration control “B” – validation of the filtration procedure |
| 26 | 5.5.4.3.4 Method validation C – validation of the membrane filtration method or counting of the fungi on the membranes which have previously been in contact with the mixture of product and interfering substance 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 VC-values |
| 27 | 5.6.2 Calculation 5.6.2.1 General 5.6.2.2 Determination of VC-values 5.6.2.3 Calculation of N and N0 |
| 28 | 5.6.2.4 Calculation of Na |
| 31 | 5.6.2.5 Calculation of NV, NV0 and NVB 5.6.2.6 Calculation of A, B and C |
| 32 | 5.7 Verification of methodology 5.7.1 General 5.7.2 Control of weighted mean counts 5.7.3 Basic limits 5.7.4 Additional limits for Aspergillus brasiliensis 5.8 Expression of results and precision 5.8.1 Reduction |
| 33 | 5.8.2 Control of active and non-active product test solution (5.4.2) 5.8.3 Limiting test organism and fungicidal and yeasticidal concentration 5.8.3.1 Fungicidal concentration 5.8.3.2 Yeasticidal concentration 5.8.4 Precision, repetitions 5.9 Interpretation of results – conclusion 5.9.1 General |
| 34 | 5.9.2 Fungicidal activity for instrument disinfection products 5.9.3 Fungicidal activity for surface disinfection products 5.9.4 Yeasticidal activity for handrub and handwash products 5.9.5 Yeasticidal activity for instrument disinfection products 5.9.6 Yeasticidal activity for surface disinfection products 5.9.7 Qualification for certain fields of application 5.10 Test report |
| 37 | Annex A (informative) Referenced strains in national collections |
| 38 | Annex B (informative) Neutralizers and rinsing liquids |
| 40 | Annex C (informative) Graphical representation of test procedures C.1 Dilution-neutralization method |
| 42 | C.2 Membrane filtration method |
| 44 | C.3 Dilution-neutralization method (modified method for ready-to-use products) |
| 46 | C.4 Membrane filtration method (modified method for ready-to-use products) |
| 48 | Annex D (informative) Example of a typical test report |
| 52 | Annex E (informative) Precision of the test result |
| 55 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC |
