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BS EN 17846:2023

BS EN 17846:2023

$189.07

Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of sporicidal activity against Clostridioides difficile 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 2023 46
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requirements for sporicidal activity against spores of Clostridioides difficile 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 document is applicable 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. Due to the new methods of application of surface disinfectants like pre-impregnated wipes this document was established to cover the different application method. The document is applicable for four method of application of products for wiping and/or mopping: a) soaking any non-specified wipe or mop with product; b) spraying the product on any non-specified wipe and / or mop or a specified wipe or mop. c) impregnation of specified wipes or mops by the user with the product according to the manufacturer’s recommendation; d) pre-impregnation of specified wipes or mops by the manufacturer as ready-to-use wipes or mops. In all types of application the water control has to be done with the standard wipe [5.3.2.17 a)], because it is a process or method control. This document does not apply to products that are sprayed on or flooding surfaces, then left until the contact application phase 2, step 2 standards without mechanical action should be used and their methods performed. The test surface (5.3.2.16) was selected as standard surface and should cover all non-porous surfaces. It was not intended to cover the influence of each different surface. This document is applicable 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
2 undefined
7 1 Scope
2 Normative references
8 3 Terms and definitions
4 Requirements
9 5 Test methods
5.1 Principle
5.2 Materials and reagents
5.2.1 Test organism
10 5.2.2 Culture media and reagents
5.2.2.1 General
5.2.2.2 Water
5.2.2.3 Medium
5.2.2.4 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 – General
5.2.2.8 Interfering substances
12 5.3 Apparatus and glassware
5.3.1 General
5.3.2 Usual microbiological laboratory equipment)
16 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)
5.4.1.5 Validation suspension (NV)
17 5.4.1.6 Incubation and counting of the test suspensions
5.4.2 Product test solution
18 5.5 Procedure for assessing the sporicidal activity against C. difficile of the product
5.5.1 General
5.5.1.1 Experimental conditions
5.5.1.2 Selection of neutralizer
19 5.5.1.3 General instruction for validation and control procedures
5.5.1.4 Equilibration of temperature
5.5.1.5 Precautions for manipulation of test organisms
5.5.1.6 Inoculation of the test-surface
20 5.5.2 Method
5.5.2.1 General
5.5.2.2 Test Na (Determination of sporicidal concentrations), water control NW
22 5.5.2.3 Neutralizer control B – verification of the absence of toxicity of the neutralizer
5.5.2.4 Method validation C – dilution-neutralization validation
5.5.2.5 Incubation and counting of the test mixture
23 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
24 5.6.2.2 Determination of VC-values
5.6.2.3 Calculation of N
25 5.6.2.4 Calculation of Na, NW, DC0, DCt
28 5.6.2.5 Calculation of NV and NV0
5.6.2.6 Calculation of B and C
29 5.7 Verification of methodology
5.7.1 General
5.7.2 Control of weighted mean counts
5.7.3 Basic limits test microorganisms for sporicidal activity
5.8 Expression of results and precision
5.8.1 Overview of the different suspensions / test mixtures
30 5.8.2 VC-values
5.8.3 Limiting test organism and sporicidal concentration
31 5.8.4 Precision, repetitions
5.9 Interpretation of results – conclusion
5.10 Test report
34 Annex A (informative)Referenced strain in national collections
35 Annex B (informative)Neutralizers
37 Annex C (informative)Graphical representations of the test method
39 Annex D (informative)Example of a typical test report

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BS EN 17846:2023
$189.07