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BS EN 16615:2026 - TC Tracked Changes. Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity on non-porous surfaces with, 2026
- A-30460213.pdf [Go to Page]
- undefined
- European foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Requirements
- Table 1 — Experimental conditions
- 5 Test methods [Go to Page]
- 5.1 Principle
- 5.2 Materials and reagents [Go to Page]
- 5.2.1 Test organism
- 5.2.2 Culture media and reagents [Go to Page]
- 5.2.2.1 General
- 5.2.2.2 Water
- 5.2.2.3 Medium
- 5.2.2.4 Diluent
- 5.2.2.5 Neutralizer
- 5.2.2.6 Sterile defibrinated sheep blood
- 5.2.2.7 Hard water for dilution of products
- 5.2.2.8 Interfering substances [Go to Page]
- 5.2.2.8.1 General
- 5.2.2.8.2 Clean conditions (bovine albumin solution – low concentration)
- 5.2.2.8.3 Dirty conditions (mixture of bovine albumin solutions – high concentration with sheep erythrocytes)
- 5.3 Apparatus and glassware
- Figure 1 —PVC plate free foam [(20 × 50) cm, thickness 2 mm] FOREXTM classic, white matt finished, one side with foil, art. nr. SFSFOXC020RW1F marked with 4 fields
- Figure 2 — Scheme of the markings and the wipe sweep over four test fields on the test-surface [Go to Page]
- 5.4 Preparation of test organism suspensions and product test solutions [Go to Page]
- 5.4.1 Test organism suspensions [Go to Page]
- 5.4.1.1 General
- 5.4.1.2 Preservation and stock cultures of test organisms
- 5.4.1.3 Working culture of test organisms [Go to Page]
- 5.4.1.3.1 Bacteria
- 5.4.1.3.2 Fungi
- Figure 3 — Examples of appropriate cultures of A. brasiliensis ATCC 16404 after 7 d of incubation at 30 C
- Figure 4 — Example of inappropriate (not usable) culture of A. brasiliensis ATCC 16404 after 7 d of incubation at 30 C [Go to Page]
- 5.4.1.3.3 Mycobacteria
- 5.4.1.4 Test suspension (N)
- Figure 5 — Observation of conidiospores under light microscope: Presence of smooth (a) and spiny (b) spores [inappropriate (not usable) suspension]
- Figure 6 — Observation of conidiospores under light microscope: High concentration of characteristic mature spores with spiny aspect (appropriate suspension) [Go to Page]
- 5.4.1.5 Validation suspension (NV)
- 5.4.1.6 Incubation and counting of the test suspensions
- 5.4.2 Product test solution
- 5.5 Procedure for assessing the bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity of the product [Go to Page]
- 5.5.1 General [Go to Page]
- 5.5.1.1 Experimental conditions
- 5.5.1.2 Selection of neutralizer
- 5.5.1.3 General instruction for validation and control procedures
- 5.5.1.4 Equilibration of temperature
- 5.5.1.5 Precautions for manipulation of test organisms
- 5.5.1.6 Inoculation of the test-surface
- 5.5.2 Method [Go to Page]
- 5.5.2.1 General
- 5.5.2.2 Test Na (Determination of bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobacericidal concentrations), water control NW
- Figure 7 — The hand pushed the unitary weight over test-surfaces without applying additional pressure [Go to Page]
- 5.5.2.3 Neutralizer control B – verification of the absence of toxicity of the neutralizer
- 5.5.2.4 Method validation C – dilution-neutralization validation
- 5.5.2.5 Incubation and counting of the test mixture
- 5.6 Experimental data and calculation [Go to Page]
- 5.6.1 Explanation of terms and abbreviations [Go to Page]
- 5.6.1.1 Overview of the different suspensions and test mixtures
- Table 2 — Number of cfu counted per ml or per 25 cm2 in the different test mixtures [Go to Page]
- 5.6.1.2 Vc-values
- 5.6.2 Calculation [Go to Page]
- 5.6.2.1 General
- 5.6.2.2 Determination of Vc-values
- 5.6.2.3 Calculation of N
- 5.6.2.4 Calculation of Na, NW, Dc0, Dct
- 5.6.2.5 Calculation of NV and NV0
- 5.6.2.6 Calculation of B and C
- 5.7 Verification of methodology [Go to Page]
- 5.7.1 General
- 5.7.2 Control of weighted mean counts
- 5.7.3 Basic limits [Go to Page]
- 5.7.3.1 Basic limits for test microorganisms for bactericidal and mycobactericidal activity
- 5.7.3.2 Basic limits for test microorganisms for yeasticidal and fungicidal activity
- 5.8 Expression of results and precision [Go to Page]
- 5.8.1 Overview of the different suspensions/test mixtures
- 5.8.2 Vc-values
- 5.8.3 Limiting test organism and bactericidal and yeasticidal concentration [Go to Page]
- 5.8.3.1 Bactericidal concentration
- 5.8.3.2 Yeasticidal concentration
- 5.8.3.3 Fungicidal concentration
- 5.8.3.4 Tuberculocidal concentration
- 5.8.3.5 Mycobactericidal concentration
- 5.8.4 Precision, repetitions
- Table 3 — Test schedule [Go to Page]
- 5.9 Interpretation of results – conclusion
- 5.10 Test report
- Annex A (informative) Referenced strains in national collections
- Annex B (informative) Neutralizers
- Annex C (informative) Graphical representations of the test method
- Figure C.1 — Graphical representations of the test method (Na)/ water control (NW) – bactericidal, mycobactericidal activity
- Figure C.2 — Graphical representations of the test method (Na)/ water control (NW) - yeasticidal and fungicidal activity
- Figure C.3 — Validation
- Annex D (informative) Example of a typical test report
- Annex E (informative) Alternative drying end point
- Annex F (informative) Additional test temperature
- Annex G (informative) Determination of the in use period of impregnated wipes
- Bibliography [Go to Page]
