In vitro skin corrosion testing according to OECD 431

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.

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 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, which 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.

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 apply 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).

Assessment of skin sensitization potential using the ARE-Nrf2 luciferase test method outlined in OECD Test Guideline 442D and listed in Annex C of ISO 10993-10 as an in-vitro alternative to traditional in vivo sensitization tests. The method has been validated for medical device extracts. The assay models the keratinocyte activation pathway — key event 2 in the skin sensitization adverse outcome pathway (AOP) as described by the OECD. Human keratinocytes are exposed to the test substance at a range of concentrations. If the substance has skin sensitization potential, it activates the Nrf2 transcription factor, which binds to the antioxidant response element (ARE) and induces luciferase expression. The measured luciferase activity thus correlates with the sensitization potential of the substance. According to Annex C of ISO 10993-10, a substance is classified as a skin sensitizer if luciferase activity increases by 50% relative to the solvent control at a concentration where cell viability is not significantly reduced. Two extracts (one polar and one non-polar) are prepared per tested device, and testing is performed in duplicate for each solvent.

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.

The biocompatibility of medical devices with breathing gas pathways is generally assessed according to ISO 18562 standards. Measurlabs offers tests according to this standard family, including the following: ISO 18562-2: Tests for emissions of particulate matter (PM), ISO 18562-3: Tests for emissions of volatile organic substances (VOS), ISO 18562-4: Tests for condensate volume and leachables from condensate. Our experts are happy to help with any questions related to the tests and prepare a quote for you. Describe your testing needs using the form below, and we will get back to you shortly.

Determination of carbon, hydrogen, nitrogen, sulfur, and oxygen content of an organic sample. CHNS analysis (”LECO analysis”) is performed using a flash combustion method, where the sample is combusted under 25 kPa of O2 at an elevated temperature (1,000 °C), followed by gas chromatography separation and detection using a thermal conductivity detector. Oxygen is analyzed by reduction on granulated carbon at 1480 °C, utilizing high-temperature thermal decomposition and conversion of oxygen into carbon monoxide before gas chromatography separation and detection with a thermal conductivity detector. The sample can be either solid or liquid, but water in the sample affects the results. In the case of aqueous samples, it is possible to dry the sample before analysis. The displayed price includes the full CHNOS package with two parallel measurements and applies to conventional organic samples. The results are reported as wt-% of the initial sample. The addition of ash, drying, and dry loss measurements will increase the minimum required sample material to 300 mg. The analysis gives the total carbon, hydrogen, nitrogen, sulfur, and oxygen content of the material, but it does not identify any chemical structures. The measurement can be combined with other methods, such as GC-MS, 1H, and 13C NMR, to perform substance structure identification. Analysis can be split into the following packages: CHN, O, and S.