Bactericidal and yeasticidal efficacy of disinfectant wipes (EN 16615)

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.

We offer comprehensive test packages for verifying the quality of type II and type IIR face masks according to the EN 14683 standard. The tests included in the packages are required to label face masks with the CE marking. Medical face masks are divided into Types I and II according to their bacterial filtration efficiency. Type I masks are not intended for healthcare professionals, but for the public to prevent the spread of infectious diseases. Type II masks are further classified based on whether they are splash-resistant (Type IIR) or not (Type II). To comply with the European Standard EN 14683, Type II face masks must undergo the following quality tests: Bacterial filtration efficiency (BFE) - The ability of the face mask to filter the bacterium Staphylococcus aureus. The BFE is expressed as the percentage of colony-forming units (cfu) that have passed via aerosol through the facemask. If a face mask consists of two or more areas with different characteristics, these areas will be tested separately., Breathability (Differential pressure) - The amount of differential pressure required to draw air through a measured surface area at a constant flow rate., Microbial cleanliness (Bioburden) - The measurement of colony forming units per gram as per EN ISO 11737-1., Biocompatibility - The medical face mask manufacturer shall complete a biocompatibility evaluation according to ISO 10993-1 as a surface device with limited contact. The applicable toxicology testing regimen shall also be determined.. In addition to the above, Type IIR masks require the following test: Splash resistance - Performed according to ISO 22609, this test determines the ability of a face mask to resist penetration of splashes of liquid at different pressures.. The lower displayed price applies to the Type II mask test package, while the higher price also includes the splash resistance test required for Type IIR masks.

Standard ISO 22196 outlines a method for evaluating the antibacterial activity of plastics and other non-porous surfaces. The procedure involves inoculating the sample with a specified concentration of bacteria, typically Staphylococcus aureus or Escherichia coli, and incubating it under controlled conditions. After incubation, the number of viable bacteria on the test surface is compared to that on an untreated control surface. The difference is quantified as a logarithmic reduction, indicating the level of antibacterial activity. This method is widely recognized as reproducible and consistent, making it a reliable tool for assessing the efficacy of antibacterial treatments in industries such as healthcare, packaging, and consumer products. The lower end of the price range applies to testing with one bacterial strain, while the higher end includes analyses with both S. aureus and E. coli.

The bacterial reverse mutation (AMES) test is used to evaluate the genotoxic effect of a medical device or its extract when in contact with a bacterial suspension. The test is conducted according to OECD 471 and ISO 10993-3 by exposing a bacterial suspension of Salmonella spp and Escherichia coli to 5 concentrations of the medical device or its pure extracts. The AMES test is a preliminary "screening test" for genotoxicity. A full genotoxicity evaluation usually includes testing the device with two in vitro methods, of which AMES is typically performed first. An additional in vivo method can be used if needed. Measurlabs can support you with the full genotoxicity evaluation. Please contact our experts for a quote.

Sterility testing measures the growth of microorganisms on a product after the product has been sterilized. ISO 11737-2 is a harmonized standard for evaluating the sterility of medical devices by the EU Medical Device Regulation, as well as an FDA-recognized consensus standard for supporting 510(k) submissions. A sterile device or product is free from viable microorganisms. The purpose of sterilization is to inactivate microbiological contaminants to transform devices from a non-sterilized to a sterilized state. Sterility can be assessed when defining, validating, or maintaining a sterilization process. Testing according to ISO 11737-2 includes method validation by determining the initial bacterial count of control suspensions and testing the suitability of the culture media for aerobic and anaerobic bacteria and fungi. Also, the suitability of the test for the specific product is assessed. This example testing package includes the following: Testing of 3 identical specimens, Detecting the presence of aerobic and anaerobic microbes and fungi (yeast and molds), Validation of the sterility determination technique, The results are given as negative (no growth observed) or positive (growth observed). The price includes one result per micro-organism per product.. We can also offer a custom sterility test package for your needs, especially for large sample volumes. Please ask our experts for a quotation and estimated turnaround time

In vitro assessment of skin sensitization potential using the human Cell Line Activation Test (h-CLAT) outlined in OECD Test Guideline 442E. Testing can be performed under GLP conditions. We offer this test primarily for liquid medical devices, but other chemicals can also be analyzed. Results can be used for UN GHS skin sensitizer classification, and they can support skin sensitization hazard assessments within the ISO 10993 biological evaluation framework. Testing is performed in two steps: first, a dose-finding assay with cytotoxicity assessment identifies appropriate non- or sub-cytotoxic concentrations. The main assay then measures CD86 and CD54 surface marker expression by flow cytometry using fluorochrome-tagged antibodies. Results are expressed as relative fluorescence intensity (RFI) versus the solvent control and interpreted using the h-CLAT prediction model to yield a Positive (GHS Category 1 sensitizer) or Negative classification.

High-resolution imaging with a transmission electron microscope (TEM) for capturing morphology, crystal structure, and defects at nanometer resolution. Typically, several images with varying magnifications are taken to get a good overview of the sample. We also provide FIB preparation to analyze the cross-section of any specific site of interest, including microelectronic stacks and loose powders. HR-TEM for atomic-level resolution, STEM for high-contrast images, and cryo-TEM for sensitive samples are also possible. For complementary compositional analysis along with the structural data, TEM-EDX and TEM-EELS elemental analyses are available. Contact us for more details.

Imaging of the sample using scanning electron microscopy (SEM). Typically, several images are taken with varying magnifications to get a good overview of the sample. Non-conductive samples can be prepared with a metallic coating to allow imaging. For cross-section measurement, additional preparation might be needed: FIB, BIB, or freeze fracturing. Cryo preparation is available for biological materials and other sensitive sample types. If compositional analysis is also needed, please see the SEM-EDX measurement. We also offer high-temperature SEM analyses at temperatures up to 1400 °C. Do not hesitate to ask for a quote.

The ASTM F1608 method is used to determine the passage of airborne bacteria through porous materials used in the packaging of sterile medical devices. With the test, different materials can be compared to determine which one offers the best protection against contamination. A mist of bacteria spores (Bacillus atrophies) is sprayed on the porous testing material in an exposure chamber. Spores that get through the material are trapped on a special filter and counted. The number of spores sprayed originally is compared to the number of spores that got through to conclude how well the material blocks the bacteria.  The results are expressed as a “Log Reduction Value” (LRV), representing the effectiveness of the material in preventing bacteria from passing.

The term bioburden describes the presence of microorganisms on a product, raw material, or surface. Bioburden testing plays a crucial role in the quality control of medical devices, pharmaceutical products, and their components. This analysis follows the ISO 11737-1 standard to detect populations of viable microorganisms on a product before sterilization, indicating the microbiological cleanliness of the product. ISO 11737-1 is recognized in the EU as a harmonized medical device standard and by the FDA as a consensus standard. This makes it the recommended way to evaluate bioburden under the EU MDR and the FDA 510(k) premarket submission process. This example testing package includes the following: Testing of 3 identical specimens, Detecting the presence of aerobic bacteria and fungi (yeasts and molds), Validating the bioburden determination technique, Results expressed as total CFU/test product (CFU=colony forming units). We can also offer custom bioburden test packages, especially for customers with large annual sample volumes. Please ask our experts for a quotation and estimated turnaround time.