BS EN 1500:2013
$167.15
Chemical disinfectants and antiseptics. Hygienic handrub. Test method and requirements (phase 2/step 2)
| Published By | Publication Date | Number of Pages |
| BSI | 2013 | 42 |
This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of transient microbial flora on hands when rubbed onto the artificially contaminated hands of volunteers. NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions. This European Standard applies to products for hygienic handrub for use in 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 patient. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. NOTE 2 This method corresponds to a phase 2, step 2 test.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 6 | 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements 5 Test method 5.1 Principle |
| 7 | 5.2 Materials and reagents 5.2.1 Test organism 5.2.2 Culture media and reagents 5.2.2.1 General 5.2.2.2 Water 5.2.2.3 Tryptone soya agar and tryptone soya selective agar |
| 8 | 5.2.2.4 Tryptone Soya Broth (TSB) 5.2.2.5 Neutralizer |
| 9 | 5.2.2.6 Diluted soft soap 5.2.2.7 Hard water for dilution of products 5.2.2.8 Propan-2-ol as reference handrub (52,3 % (weight concentration) corresponding to 60 % (volume concentration) at 20 C( |
| 10 | 5.3 Apparatus and glassware 5.3.1 General 5.3.2 Usual microbiological laboratory equipment1F ) and, in particular, the following: |
| 11 | 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 5.4.1.4 Test suspension (“N”)/ contamination fluid |
| 12 | 5.4.1.5 Validation suspension (“Nv”,“NvB”) 5.4.1.6 Incubation and counting of the test and the validation suspensions |
| 13 | 5.4.2 Product test solutions 5.5 Procedure for assessing the bactericidal activity of the product on volunteers’ hands 5.5.1 General 5.5.1.1 Experimental conditions 5.5.1.2 Neutralization |
| 14 | 5.5.1.3 Equilibration of temperature 5.5.1.4 Selection of volunteers 5.5.1.5 Experimental design 5.5.2 Neutralization – control and validation4F ) 5.5.2.1 Neutralizer control “B” – verification of the absence of toxicity of the neutralizer |
| 15 | 5.5.2.2 Method validation “C” 5.5.3 Test procedure with volunteers 5.5.3.1 Application of the contamination fluid 5.5.3.2 Sampling of the test organisms before treatment (“Prevalue”) |
| 16 | 5.5.3.3 Hygienic handrub procedure 5.5.3.3.1 General 5.5.3.3.2 Reference hygienic handrub procedure (RP) 5.5.3.3.3 Hygienic handrub procedure with product under test (PP) 5.5.3.3.4 Sampling of the test organisms after treatment (“Postvalue”) |
| 17 | 5.5.4 Incubation and counting of the test mixture and the control and validation mixtures 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 |
| 18 | 5.6.2.3 Calculation of N 5.6.2.4 Calculation of Nv, Nvo and NvB |
| 19 | 5.6.2.5 Calculation of B and C 5.6.2.6 Calculation of the lg reduction R (lg prevalue minus lg postvalue) |
| 20 | 5.7 Verification of the methodology – Test validation 5.7.1 Acceptance criteria for test results |
| 21 | 5.7.2 Control of weighted mean counts 5.7.3 Basic limits 5.8 Statistical evaluation (significance testing), expression of results and precision 5.9 Conclusion |
| 22 | 5.10 Test report |
| 24 | Annex A (normative) Standard handrub procedure |
| 25 | Annex B (informative) Neutralizers and rinsing liquids |
| 27 | Annex C (informative) Control and validation of neutralization |
| 28 | Annex D (informative) Quality control of soft soap5F ) |
| 29 | Annex E (informative) Examples of reporting of results and significance testing |
| 37 | Annex F (normative) Test for non-inferiority 6F ) |
