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BS EN 16615:2015 pdf free download

BS EN 16615:2015 pdf free download.Chemical disinfectantsand antiseptics – Quantitativetest method for the evaluationof bactericidal and yeasticidalactivity on non-poroussurfaces with mechanicalaction employing wipes in themedical area (4- field test)一Test method and requirements(phase 2, step 2).
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
EN 12353, Chemical disinfectants and antiseptics — Preservation of test organisms used for the determination of bactencidal (including Legionella), mycobactericidal, sporicidal. fun gicidal and virucidal (including bacteriophages) activity
EN 13624, Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of fungicidal or yeastiidal activity in the medical area — Test method and requirements (phase 2, step 1)
EN 13727. Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of bactericidal activity in the medical area — Test method and requfrements (phase 2. step 1)
EN 14885, Chemical disiofectants and antiseptics — Application of European Standards for chemical disinfectants and antiseptics
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 14885 apply.
4 Requirements
The product, when diluted with hard water or — in the case of ready-to-use products — with water, and tested in accordance with Clause 5 under simulated clean conditions (0,3 gIl bovine albumin) or simulated dirty conditions (3,0 g/l bovine albumin + 3.0 mIll sheep erythrocytes) according to its practical applicatioi,s and under the following test conditions: four selected test organisms, temperature between 4 °C and 30 °C,contact time mm. 1 mm and max. either 5 mm or 60 mini) shall demonstrate at least a decimal log (Ig)
reduction in counts of 5 (Staphylococcus aureus, Enterococcus hirae, Pseudomonas aeruginosa),or 4
(Candida albicans) on test field 1. The mean of the clus on the test fields 2 to 4 shall be equal or less than 50,
the mean of the cfus of the water control shall be equal or more than 10.
The bactericidal activity shall be evaluated using the following test organisms: Staphylococcus aureus, Enterococcus h/rae, Pseudomonas aeruginosa. The yeasticidal activity shall be evaluated using the following test organism: Candida albicans.
Where indicated, additional specific bactericidal and yeasticidal activity shall be determined applying other contact times and test organisms in order to take into account intended specific use conditions.
NOTE For these additional conditions, the concentration defined as a result can be lower than the one obtained under the minimum test conditions.
5 Test methods
5.1 Principle
5.1.1 A test-surface is marked with 4 squares of 5 x 5 cm, the test fields’, in a row. Test field 1 on the test- surface is inoculated with a test suspension of bacteria or yeasts in a solution of interfering substances, The inoculum Is dried. A wipe is soaked with a sample of the product as delivered and/or diluted with hard water (for ready to use products: water). The test-surface is wiped with the soaked wipe across the four marked test fields, starting in front of test field 1. turning immediately after test field 4 and wiped back to the starting point. In parallel a water control is performed: a wipe is soaked with water ( e)) instead of the product.
Temperature, soiling and contact time are employed as recommended by the manufacturer. At the end of the contact time, the test organisms are recovered from each test field with moistened cotton swabs. The swabs are brought into a tube containing broth and neutralizer and the test organisms are to be severed from the swab by shaking. The numbers of surviving test organisms in each sample are determined, and the reduction is calculated by comparing the results of the drying control Dc1 and the results obtained with the product. In parallel to the test with the product water is applied in the same way to ensure that the test organisms are spread on the 4 fields and their number reaches a certain level. The test is performed using P. aeruginosa, S. aureus. E. hiree and C. albicans as test organisms (minimum test conditions).
5.1.2 Additional test organisms (only bacterial or fungal strains), contact times and interfering substances can be used.BS EN 16615 pdf download.

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