Medical electrical equipment testing by IEC 60601-1

Chemical characterization by the ISO 10993-18 standard is performed to identify the constituents of a medical device and to estimate and control the risks associated with its chemical composition. The test is a key part of assessing the biocompatibility of medical devices. Chemical characterization includes the estimation of substances released under simulated or exaggerated laboratory conditions (extractables) or the detection of actually released substances (leachables) by the medical device during clinical use. Applicable methods may include HS-GC (volatile organic compounds), GC-MS (semi-volatile organic compounds), LC-MS (non-volatile organic compounds), and ICP-MS (inorganic elements). Suitable tests, solvents, and analysis methods are chosen according to the device's composition, intended contact time, and site. We provide a range of chemical characterization tests based on the market area (MDR, FDA) and quality requirements (GLP). The tests are always customized for the product. Any chemicals detected above the concentrations established to be safe require further evaluation, typically through a toxicological risk assessment (ISO 10993-17). The starting price is based on the chemical characterization of volatile organic compounds (GLP, FDA).

Diesel exhaust fluid (DEF) is an additive used in diesel-powered vehicles to help the catalytic reduction of nitrous oxides. Thus, the use of AdBlue and other exhaustive fluids improves ambient air quality. DEF testing package according to ISO 22241:2019 includes the measurements listed below: Urea content (ISO 22241-2C), Density at 20 °C (EN ISO 12185) , Refractive index at 20 °C (ISO 22241-2C), Alkalinity as NH₃ (ISO 22241-2D), Biuret (ISO 22241-2E), Aldehydes (ISO 22241-2F), Insoluble matter (ISO 22241-2G), Phosphate (ISO 22241-2H), Determination of Al, Ca, Cr, Cu, Fe, K, Mg, Na, Ni, and Zn content (ISO 22241-2I).

This test is used to evaluate the color fastness of dyed or printed paper or board that is intended to come into contact with food. The applied simulants are Olive oil, 3% acetic acid, Alkaline salt solution (saliva simulant), Distilled water. Color transfer is assessed against a greyscale according to standard EN 646.

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.

A dilatometer is used to determine the linear thermal expansion of a material as a function of temperature. The temperature range of the measurement is generally between 25 °C and 1,600 °C. There is also an option to perform the test in a cryogenic atmosphere, which ranges from -175 °C to 300 °C. The typical heating rate is 3 °C/min. As a result of the measurement, you will get the coefficient of thermal expansion (CTE) and the absolute change in sample length, both as a function of temperature. The testing can be performed in various atmospheres, including air, argon, CO₂, N₂, and O₂. Please contact us to get a quote. The price will depend on the testing conditions, so please specify them as precisely as possible.

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).

The peroxide value (PV) measures hydroperoxides formed as a result of the autoxidation of unsaturated fatty acids in food and feed products. Accumulation of autoxidation products affects sensory quality and is potentially harmful to human and animal health, making PV an important quality indicator in the food industry. Autoxidation reactions occur at different rates during the manufacturing, storage, and use of food and feed, but are generally sped up with elevated temperatures and exposure to light. This method includes an extraction step, after which the determination of peroxide value is performed on the extracted fat or oil. The method is suitable for all food and feed products that contain fat.

This test is designed to measure the oxygen transmission rate of finished packages, including cups, bottles, trays, and containers. Two replica measurements are included in the displayed price. Temperature can be adjusted from 15 to 55 °C, and relative humidity can be either 0% or between 5 and 90% RH. This test is not suitable for films. Please see the oxygen transmission rate (OTR) of films and sheeting if you need testing for film samples. Please specify the sample dimensions and testing conditions upon ordering.

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.