Oona Korhonen

Quantitative suspension test (phase 2, step 1) measuring the bactericidal activity of chemical disinfectants and antiseptics for use in medical areas. The method is accepted for efficacy documentation under the EU Biocidal Products Regulation (Regulation (EU) No 528/2012). The following bacterial strains are used as test organisms: Pseudomonas aeruginosa, Staphylococcus aureus, Enterococcus hirae, Escherichia coli K12 (hygienic handrub and handwashing), Enterococcus faecium (medical instrument disinfection at ≥40°C). Appropriate test conditions depend on the intended use of the product: Application Temperature Contact time Conditions Hygienic handrub 20°C 30–60 seconds Clean Hygienic handwashing 20°C 30–60 seconds Dirty; max. product concentration 50% Surgical handrub 20°C 1–5 minutes Clean Surgical handwashing 20°C 1–5 minutes Dirty Instrument disinfection 20–70°C ≤60 minutes Clean or dirty Surface disinfection (patient-adjacent) 4–30°C ≤5 minutes Clean or dirty Surface disinfection (other surfaces) 4–30°C ≤60 minutes Clean or dirty The product is tested at a minimum of three concentrations, including at least one in the non-active range and one in the active range. Testing is performed by either the dilution-neutralization method or the membrane filtration method. Surviving bacteria are enumerated by viable counts (CFU/mL), and performance is calculated as the log₁₀ reduction relative to untreated controls. The acceptance criterion is a log₁₀ reduction of ≥5 in viable cell count. For hygienic handwashing products, a reduction of ≥3 log₁₀ applies. Ready-to-use products that do not pass at 80% concentration may be tested at 97%. Please indicate the following when submitting a request: intended use, test temperature, test conditions (clean or dirty), contact time, and product concentration(s) to be tested.

Determination of protective gloves' and other barrier materials' resistance to permeation by liquid chemicals under continuous contact in accordance with EN 16523-1. One side of the sample is placed in contact with a challenge chemical in a permeation cell, and the rate at which the chemical permeates the material is determined by periodically sampling the collection medium on the side of the sample. The breakthrough time is the time at which the permeation rate reaches 1 µg/cm2/min. Testing is performed in triplicate, and the permeation curves and breakthrough times are reported for each specimen. The results can be used to categorize the chemical permeation performance level of protective gloves per ISO 374-1. Available challenge chemicals include, e.g., methanol, ethanol, acetone, toluene, and n-heptane. Please specify the challenge chemical(s) when requesting an offer. Determination of resistance to degradation (EN 374-4) is also available.