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BS EN 17854:2024

BS EN 17854:2024

$189.07

Antimicrobial wound dressings. Requirements and test method

Published By Publication Date Number of Pages
BSI 2024 50
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PDF Catalog

PDF Pages PDF Title
2 undefined
8 1 Scope
2 Normative references
3 Terms, definitions, symbols and abbreviated terms
3.1 Terms and definitions
10 3.2 Symbols and abbreviated terms
11 4 Requirements
4.1 Documentation and training
12 4.2 Microbicidal dressings
4.3 Microbistatic dressings
4.4 Performance table
5 Test method
5.1 Principle
13 5.2 General conditions
5.2.1 Volumes
5.2.2 Agar plates
5.3 Materials and reagents
5.3.1 Test organism strains
5.3.1.1 Storage of organisms
5.3.1.2 Bacteria
5.3.1.3 Yeast
14 5.3.1.4 Additional test organism strains
5.3.2 Reagents and culture media
5.3.2.1 General
5.3.2.2 Water
5.3.2.3 Tryptone Soya Broth (TSB)
15 5.3.2.4 Tryptone Soya Agar (TSA)
5.3.2.5 Simulated Wound Fluid (SWF)
5.3.2.6 Maximum recovery diluent (MRD)
5.3.2.7 Sabouraud broth (SAB)
5.3.2.8 Sabouraud agar (SAA)
16 5.3.2.9 Neutralizer
5.3.3 Test apparatus
17 5.4 Preparation of test and negative control dressings
5.5 Calculation of saturation volume and working volume
19 5.6 Preparation of test organism suspensions
5.6.1 Bacteria
20 5.6.2 Yeast
5.6.3 Preparation of STOCK A
21 5.7 Neutralization validation
5.7.1 General
5.7.2 Preparation of inoculum
22 5.7.3 Neutralizer toxicity
5.7.4 Test organism viability
5.7.5 Neutralizer efficacy
23 5.7.6 Interpretation of data
25 5.8 Procedure
5.8.1 Exposing the test and negative control dressings to test organisms
27 5.8.2 Recovery and enumeration of test organisms
28 5.8.3 Calculation and expression of results
30 5.8.4 Calculation of the detection limit of the test
31 5.8.5 Judgement of test validity
5.9 Test report
33 Annex A (informative)Referenced test organism strains in other national collections
34 Annex B (informative)Validation of neutralization
B.1 Principle
B.2 Neutralizer selection
35 Annex C (informative)Neutralizers
36 Annex D (informative)Rationale
D.1 General
D.2 Title
D.3 Test organism strains
37 D.4 Preparation of test organism suspensions
D.5 Cutting dressings
D.6 Positive control
D.7 Performance requirements
38 D.8 Media
D.9 Incubation temperatures
D.10 Dressing classification
D.11 Saturation volume
D.12 Procedure
39 D.13 Exposure times
D.14 Pre-conditioning and repeat challenge testing
D.15 Humidity
D.16 Recovery of test organisms from dressings
40 Annex E (informative)Replicates
41 Annex F (informative)Test method illustrations
46 Annex G (informative)Example Test Report Tables

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BS EN 17854:2024
$189.07