BS EN 16615:2015
$167.15
Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test). Test method and requirements (phase 2, step 2)
| Published By | Publication Date | Number of Pages |
| BSI | 2015 | 44 |
This European Standard specifies a test method and the minimum requirements for bactericidal and yeasticidal 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 European Standard applies to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping – regardless if they are covered by the 93/42/EEC Directive on Medical Devices or not. This European Standard includes ‘ready-to-use wipes‘ which are impregnated with a microbicidal solution. This European Standard 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 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 |
|---|---|
| 4 | Content Page |
| 7 | 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements |
| 8 | 5 Test methods 5.1 Principle 5.2 Materials and reagents 5.2.1 Test organism |
| 9 | 5.2.2 Culture media and reagents 5.2.2.1 General 5.2.2.2 Water |
| 10 | 5.2.2.3 Medium a) Soya Agar (TSA) 5.2.2.4 Diluent a) General Diluent |
| 11 | 5.2.2.5 Neutralizer 5.2.2.6 Sterile defibrinated sheep blood 5.2.2.7 Hard water for dilution of products |
| 12 | 5.2.2.8 Interfering substances 5.3 Apparatus and glassware 5.3.1 General 5.3.2 Usual microbiological laboratory equipment ) |
| 15 | 5.4 Preparation of test organism suspensions and product test solutions 5.4.1 Test organism suspensions 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 5.4.1.4 Test suspension (N) |
| 16 | 5.4.1.5 Validation suspension (NV) 5.4.1.6 Incubation and counting of the test suspensions |
| 17 | 5.4.2 Product test solution 5.5 Procedure for assessing the bactericidal and yeasticidal activity of the product 5.5.1 General 5.5.1.1 Experimental conditions |
| 18 | 5.5.1.2 Selection of neutralizer 5.5.1.3 General instruction for validation and control procedures 5.5.1.4 Equilibration of temperature |
| 19 | 5.5.1.5 Precautions for manipulation of test organisms 5.5.1.6 Inoculation of the test-surface 5.5.2 Method) 5.5.2.1 General 5.5.2.2 Test Na (Determination of bactericidal and yeasticidal concentrations), water control NW |
| 20 | 5.5.2.3 Neutralizer control B – verification of the absence of toxicity of the neutralizer |
| 21 | 5.5.2.4 Method validation C – dilution-neutralization validation 5.5.2.5 Incubation and counting of the test mixture |
| 22 | 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 5.6.2 Calculation 5.6.2.1 General 5.6.2.2 Determination of VC-values |
| 23 | 5.6.2.3 Calculation of N and NW 5.6.2.4 Calculation of Na |
| 26 | 5.6.2.5 Calculation of NV and NV0 |
| 27 | 5.6.2.6 Calculation of B and C 5.7 Verification of methodology 5.7.1 General 5.7.2 Control of weighted mean counts |
| 28 | 5.7.3 Basic limits 5.8 Expression of results and precision 5.8.1 Overview of the different suspensions / test mixtures 5.8.2 VC-values |
| 29 | 5.8.3 Limiting test organism and bactericidal and yeasticidal concentration 5.8.3.1 Bactericidal concentration 5.8.3.2 Yeasticidal concentration 5.8.4 Precision, repetitions 5.9 Interpretation of results – conclusion |
| 30 | 5.10 Test report |
| 32 | Annex A (informative)Referenced strains in national collections |
| 33 | Annex B (informative)Neutralizers |
| 34 | Annex C (informative)Graphical representations of the test method |
| 37 | Annex D (informative)Example of a typical test report |
| 41 | Annex ZA (informative)Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC |
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