Antibacterial activity on plastic and non-porous surfaces by ISO 22196

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.

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 by ISO 11737-2 includes method validation by determining the initial bacterial count of control suspensions and testing the suitability of the culture mediums for aerobic and anaerobic bacteria and fungi. Also, the suitability of the test for the specific product is assessed. This example testing package includes following: Testing of 3 identical specimens, Detecting the presence of aerobic, 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), and 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

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. If compositional analysis is also needed, please see the SEM-EDX measurement.

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, thus 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 5 identical specimens, Detecting the presence of aerobic bacteria and and fungi (yeasts and molds), Validating the bioburden determination technique, Results expressed as total CFU/test product (CFU=colony forming units), Tests under GLP. We can also offer a custom bioburden test package for your needs, especially for large sample volumes. Please ask our experts for a quotation and estimated turnaround time.

Cyclosiloxanes are the primary building blocks of siloxane polymers and, ultimately, silicone rubber. Hence, cyclosiloxanes can remain in the final silicone article as residual impurities. Several cyclosiloxanes (D4, D5, D6; see table below) are considered harmful to the environment and human health. These three substances are listed in the REACH Candidate List of substances of very high concern (SVHC). Substance Abbreviation CAS N:o Octamethylcyclotetrasiloxane D4 556-67-2 Decamethylcyclopentasiloxane D5 541-02-6 Dodecamethylcyclohexasiloxane D6 540-97-6 The Nordic Swan Ecolabel criteria for greaseproof paper sets the limit values for D4, D5, and D6 impurities in silicone coating as 400 ppm per substance and 1000 ppm for the sum of D4, D5, and D6. In addition to the restricted substances listed above, this analysis package includes the quantification of cyclosiloxanes D3, D7, and D8.

X-Ray Reflectometry (XRR) analysis is used to measure the density (g/cm3), thickness (nm), and roughness (nm) of thin films. The method is applicable to the characterization of single- or multilayered thin films, as it provides information on the thickness and density of individual layers of the sample material as well as the roughness of the interphases. Greatest accuracy for XRR thickness measurements is generally achieved for samples containing 1-150 nm thick surface layers with under 5 nm RMS roughness. Thicker films and coatings with rougher surfaces can also be characterized, but the accuracy of thickness determination decreases as the thickness and roughness of the film or film stack increase. >150 mm wafers are typically cut to fit the sample holder. Please let us know if you need testing for larger wafers that cannot be cut into pieces. The available temperature range for XRR measurements is 25-1100 °C, and crystallinity can be studied as a function of temperature. The measurements can be performed under a normal atmosphere, inert gas, or vacuum. Measurements are typically performed using one of the following instruments: Rigaku SmartLab, Panalytical X'Pert Pro MRD, Bruker D8 Discover. Please let us know if you have a preference for a specific instrument.

The purpose of cleaning validation studies is to show that reusable medical devices can be reprocessed effectively between uses so that patients are not exposed to pathogens. Depending on the device’s intended use and classification, appropriate reprocessing steps may include cleaning, disinfection, and/or sterilization. For cleaning validation more specifically, the testing procedure consists of three steps: Simulated contamination with artificial soils that accurately reflect clinically relevant soils, such as blood and other bodily fluids. , Cleaning (manual and/or automated), carefully following the manufacturer's instructions for parameters such as detergents, cleaning tools, water quality, and temperature. , Inspection, both visually and using quantitative methods relevant to the test soil (e.g. proteins, total organic carbon, or hemoglobin) to assess whether residual contaminants remain on the device.. Successful cleaning validation is often sufficient for non-critical reusable devices, such as blood pressure cuffs, monitors, and clutches. Semi-critical and critical devices will require further disinfection and/or sterilization validation studies that we can also offer. The displayed example price covers a manual cleaning validation study with 6 reprocessing cycles and cleanability evaluations with visual inspection & protein content measurement. Test protocol formulation and reporting are also included.

Determination of microplastics in wastewater using FTIR microspectroscopy. The results of the analysis will specify different types of polymers by size, for example, 10–50 µm, 50–100 µm, 100–500 µm, and >500 µm. This analysis is suitable for natural waters and typical wastewater samples. Please note that both of these matrices need digestion sample preparation due to the possible solid particles in the samples. For special water matrices (process water, industrial water, etc.), please contact the method expert before ordering.

ISO 10993-23 is an internationally recognized standard for assessing the irritation potential of medical devices when they come into contact with skin, mucosal membranes, or subcutaneous tissues. Irritation tests performed according to the standard are commonly used to demonstrate compliance with EU MDR and FDA requirements. The appropriate testing approach is chosen based on the body contact site: Skin irritation tests evaluate whether a medical device or material causes localized skin irritation when it comes into direct contact with the skin. Testing can be conducted using in vivo or in vitro methods, depending on the device and the market area. , Intracutaneous reactivity tests are applied to medical devices or materials that penetrate the skin or come into contact with deeper tissues. The goal is to determine whether extracts from such devices cause localized inflammatory responses in the dermis or subcutaneous layers.. The device itself is tested with a direct contact method, when possible. Alternatively, polar and non-polar solvents are used to prepare extracts that simulate potential leachables from the device. The displayed example price includes an in vivo direct skin irritation test performed under GLP. For a more accurate quote, do not hesitate to contact us with a description of your device and any additional requirements you may have for testing (e.g., market area, quality systems, in vivo vs. in vitro methods).