BSI 14/30303000 DC:2014 Edition
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BS EN 16777. Chemical disinfectants and antiseptics. Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area. Test method and requirements (phase 2/step 2)
| Published By | Publication Date | Number of Pages |
| BSI | 2014 | 33 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 5 | Foreword |
| 6 | Introduction |
| 7 | 1 Scope 2 Normative references 3 Terms and definitions |
| 8 | 4 Requirements for virucidal activity on surfaces 5 Test methods 5.1 Principle |
| 9 | 5.2 Materials and reagents, including cell cultures 5.2.1 Test organisms 5.2.2 Culture media, reagents and cell cultures 5.2.2.1 General 5.2.2.2 Water |
| 10 | 5.2.2.3 Phosphate buffered saline (PBS) 5.2.2.4 Neutral Red (1:1000 solution) 5.2.2.5 Foetal calf serum (FCS) 5.2.2.6 Trichloroacetic acid (10% solution) (TCA) 5.2.2.7 Hard water for dilution of products |
| 11 | 5.2.2.8 Interfering substance |
| 12 | 5.2.2.9 Defibrinated sheep blood 5.2.2.10 Medium for cell cultures 5.2.2.11 Cell cultures 5.3 Apparatus and glassware 5.3.1 General 5.3.2 Usual microbiological laboratory equipment) 5.3.2.1 Apparatus for sterilization (moist and dry heat) |
| 13 | 5.3.3 Test surfaces |
| 14 | 5.4 Preparation of test organism suspensions and product test solutions 5.4.1 Test organisms suspensions (test virus suspension) 5.4.2 Product test solution |
| 15 | 5.5 Procedure for assessing the virucidal activity of the product 5.5.1 Experimental conditions 5.5.2 Test procedure |
| 17 | 5.5.3 Cytotoxicity caused by product solutions 5.5.3.1 Cytotoxic effect 5.5.3.2 Interference control – control of cell susceptibility |
| 18 | 5.5.3.3 Elimination of cytotoxicity 5.5.4 Control of efficiency for suppression of disinfectant activity 5.5.4.1 Dilution in ice-cold medium 5.5.4.2 Filtration technique |
| 19 | 5.5.5 Reference test for virus inactivation 5.5.6 Titration of the virus control 5.5.7 Titration of test samples 5.6 Experimental data and calculation 5.6.1 Protocol of the results 5.6.2 Calculation of infectivity titer (TCID50 – PFU) 5.6.2.1 General |
| 20 | 5.6.2.2 Calculation of TCID50 5.6.2.3 Calculation of PFU 5.7 Verification of the methodology |
| 21 | 5.8 Expression of results 5.8.1 General 5.8.2 Calculation of the virucidal activity of products 5.9 Test report |
| 23 | Annex A (informative)Examples of viruses sorted according to their presence in the human body in case of virus infection |
| 25 | Annex B (normative)Detoxification of test mixtures by molecular sieving B.1 Molecular sieving with SephadexTM LH 20) B.1.1 Principle B.1.2 Sephadex suspension B.1.3 Procedure |
| 27 | Annex C (informative)Calculation of the viral infectivity titre C.1 Quantal tests C.1.1 Example of TCID50 determination by the Spaerman-Kärber method |
| 28 | C.2 Plaque test C.3 Biometrical evaluation of experimental approaches and assessment of the disinfecting effect on the virus (reduction [R]): C.3.1 General |
| 29 | C.3.2 Calculating the virus titre with 95% confidence interval C.3.3 Calculating the reduction and its 95% confidence interval |
| 30 | C.3.4 Calculating the average reduction (R(mi)) and its 95% confidence interval. |
| 31 | C.3.5 Practical example |
