BS EN 12791:2016+A1:2017:2018 Edition
$167.15
Chemical disinfectants and antiseptics. Surgical hand disinfection. Test method and requirements (phase 2, step 2)
| Published By | Publication Date | Number of Pages |
| BSI | 2018 | 34 |
This European Standard specifies a test method simulating practical conditions for establishing whether a product for surgical handrub and handwash reduces the release of resident and eventually present transient microbial flora on hands when used for the treatment of clean hands of volunteers. This European Standard applies to products for surgical handrub or handwash 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 This method corresponds to a phase 2, step 2 test.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 6 | 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements 5 Test methods 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 (TSA) |
| 8 | 5.2.2.4 Tryptone Soya Broth (TSB) 5.2.2.5 Neutralizer 5.2.2.6 Diluted soft soap 5.2.2.7 Hard water for dilution of products |
| 9 | 5.2.2.8 Propan-1-ol as reference product [48,3 % w/w (weight concentration) corresponding to 60 % v/v (volume concentration) at 20 °C] 5.3 Apparatus and glassware 5.3.1 General 5.3.2 Usual microbiological laboratory equipment) |
| 10 | 5.4 Product test solutions |
| 11 | 5.5 Procedure for assessing the microbicidal activity of the product on volunteers’ hands 5.5.1 General 5.5.1.1 Experimental conditions 5.5.1.2 Neutralization 5.5.1.3 Equilibration of temperature 5.5.1.4 Selection of volunteers |
| 12 | 5.5.1.5 Experimental design 5.5.2 Preparatory handwash 5.5.3 Test procedure with volunteers 5.5.3.1 Sampling of the resident skin flora before treatment (“Prevalue”) |
| 13 | 5.5.3.2 Surgical handrub / handwash procedure |
| 14 | 5.5.4 Incubation and counting of the test mixture 5.6 Experimental data and calculation 5.6.1 Determination of VC-values |
| 15 | 5.6.2 Calculation of the individual lg reduction (lg R; lg prevalue minus lg postvalue) |
| 16 | 5.7 Verification of the methodology 5.7.1 Acceptance criteria for test results 5.7.2 Control of weighted mean counts 5.8 Statistical evaluation (significance testing), expression of results and precision |
| 17 | 5.9 Conclusion 5.10 Test report |
| 19 | Annex A (informative)Standard surgical handrub/-wash procedure |
| 20 | Annex B (informative)Quality control of soft soap) |
| 21 | Annex C (informative)Examples of reporting of results and significance testing |
| 32 | Annex D (informative)WILCOXON’S matched-pairs signed-ranks test |
