BSI 14/30300957 DC:2014 Edition
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BS EN 16756. Antimicrobial wound dressings. Requirements and test methods
| Published By | Publication Date | Number of Pages |
| BSI | 2014 | 35 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | 30300957 |
| 8 | 41_e_stf 1 Scope 2 Normative references 3 Terms and definitions |
| 9 | 4 Classification 5 Requirements 5.1 Microbicidal dressings 5.2 Microbistatic dressings 5.3 Performance Table 6 Information to be supplied |
| 11 | Annex A (normative) Validation of dilution-neutralisation A.1 Principle A.2 Neutralizer selection A.3 Preparation of microbial suspension A.4 Test validation |
| 12 | A.5 Neutralizer toxicity |
| 13 | A.6 Test organism viability A.7 Neutralisation Effectiveness |
| 14 | A.8 Interpretation of data |
| 15 | Annex B (informative) Neutralizers |
| 16 | Annex C (informative) Rationale C.1 Title C.2 Microbial strains |
| 17 | C.3 Cutting dressings C.4 Positive control C.5 Microbistatic requirements C.6 Performance Requirements C.7 Test method Information C.7.1 General |
| 18 | C.7.2 Direct Contact method C.7.3 Shaking Method C.7.4 Two compartment method C.8 Media C.9 Incubation Temperatures C.10 Dressing Classification |
| 19 | Annex D (informative) Apparatus |
| 20 | Annex E (informative) Reagents and culture media E.1 General E.2 Water E.3 Tryptone Soya Agar E.4 Maximum recovery diluent E.5 Simulated Wound Fluid (SWF) |
| 21 | E.6 Sabouraud agar (SAB) E.7 Neutralizer |
| 22 | Annex F (informative) Reference strains F.1 Storage of strains F.2 Bacterial strains F.3 Yeasts and molds F.4 Other Strains |
| 23 | Annex G (informative) Preparation of microbial suspensions G.1 Stock Cultures G.2 Working Culture G.2.1 Subcultures from stocks G.2.2 Preparation of suspensions on day of testing |
| 24 | Annex H (normative) Test methods H.1 Introduction H.2 Equilibration of reagents H.3 Neutralizer H.4 Choice of experimental conditions H.4.1 Contact Times H.4.2 Strains |
| 25 | H.4.3 Saturation Volume H.5 Sample Size H.6 Direct contact test method H.6.1 Microbial Suspension H.6.2 Preparation of test samples H.6.3 Exposing the dressings to test organisms |
| 26 | H.7 Shaking method H.7.1 Sampling Volume H.7.2 Microbial Test Suspension H.7.3 Preparation of test samples |
| 27 | H.7.4 Exposing the test samples to the test organisms H.8 Two compartment method H.8.1 Microbial Test Suspension H.8.2 Preparation of test samples H.8.3 Exposing the test samples to the test organisms |
| 28 | H.9 Recovery and enumeration of test organisms H. 10 Calculation and expression of results H.10.1 Calculation of Viable counts (cfu/ml) |
| 29 | H.10.2 Calculation of viable counts per sample H.10.3 Judgement of test validity |
| 30 | H.10.4 Calculation of the detection limit of the test H.10.5 Calculation of antimicrobial activity |
| 31 | H.11 Test report |
| 32 | Annex I (informative) Figures and illustrations |
| 34 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/92/EEC on medical devices |
