Laboratory testing services

A biological evaluation plan (BEP) is a critical part of assessing the safety of a medical device. It involves a detailed examination of various aspects such as the device's design & structure, its material composition, manufacturing process & potential contaminants, the intended use, existing test results, and clinical history. The BEP ensures that the device undergoes sufficient biocompatibility testing, with parameters selected from the ISO 10993-1 standard. As a manufacturer, you will need to have a BEP during the regulatory approval process to demonstrate the safety of your medical device. The BEP should be developed during the initial design phase of the medical device. At this stage, manufacturers can identify potential biological risks associated with the device's intended use, materials, and components. A new BEP or updates to the existing one may also be needed if changes are made to the device's design or material composition at a later point. At Measurlabs, we can provide a BEP for a range of medical devices while also guiding manufacturers throughout the process. Do not hesitate to contact us if you are developing a new device, seeking regulatory approval, making changes to an existing product, conducting post-market surveillance, or performing preclinical testing.  We are also happy to create an offer for biocompatibility testing according to the BEP, as well as a biological evaluation report (BER) to summarize the results of the biological evaluation.

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.

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).

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.

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.

Toxicological risk assessment by the ISO 10993-17 standard is essential for determining the biocompatibility of a medical device. After chemical characterization (ISO 10993-18) is performed to identify and quantify extractable and leachable substances, a risk assessment is necessary to evaluate the potential health risks associated with these chemicals. ISO 10993-17 provides a structured approach to establishing the safe exposure levels of leachable substances in medical devices. Comprehensive risk assessments are created using toxicological data from existing literature, and mathematical tools when data on particular substances are unavailable.  A toxicological risk assessment will include: A summary of the toxicological profile of substances flagged from the device's chemical characterization and determination of their respective permissible exposure limits., A calculation of the margin of safety between actual patient exposure and permissible exposure limits, considering various toxicological endpoints., A final assessment of whether a leachable poses a significant toxicological risk, including recommendations on ensuring compliance with safety thresholds.. The displayed starting price applies to the evaluation of a single extractable chemical and the reporting fee. Generally, multiple chemicals are evaluated during the risk assessment, and the price per chemical decreases when more chemicals are included. The extent of the required toxicological evaluation depends on the results of the ISO 10993-18 chemical characterization, which we can also offer. You can contact our experts through the form below to request a quote tailored to your medical device.

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

A biological evaluation report (BER) or biological risk assessment report (BRA) collects and evaluates the results of biological evaluation studies and concludes the medical device's biological risk. It is a comprehensive analysis considering chemical and biological test results as well as toxicological evaluation of the extractables that could be released from the device during its usage. The biological evaluation report is needed as a part of the regulatory approval and often requires strong expertise in the biological risk evaluation of medical devices, taking into account the requirements of ISO 10993- standard family and local regulations (FDA, MDR). The biological evaluation plan (BEP) and sufficient testing need to be completed before the BER can be prepared. Measurlabs can support medical device manufacturers with BER preparation. We can also provide the required testing and a BEP if these have not yet been completed.

Sterilization residue testing according to ISO 10993-7 is a crucial part of the biocompatibility assessment for medical devices that have been sterilized with ethylene oxide. During the assessment, harmful compounds originating from ethylene oxide sterilization are analyzed to ensure that the device is safe to use after sterilization. Testing is required for the regulatory approval of applicable new medical devices in the EU (under the MDR) and the US (510(k) submission to the FDA). Ethylene oxide sterilization can be used when steam sterilization is not appropriate for the device. Ethylene oxide (EO) and ethylene chlorohydrin (ECH) are irritating and toxic chemicals, and for this reason, it has to be ensured that residue levels cause minimal risk to the patient during normal product use. ISO 10993-7 sets the maximum daily doses for EO and ECH in mg/d, based on the device's exposure duration category (limited, prolonged, or permanent). Residual amounts shall not exceed these maximums. During the assessment, the product is extracted with water and the amount of ethylene oxide and ethylene chlorohydrin is determined chromatographically. Extractions are made until the cumulative exposure does not increase. The displayed example price covers both ethylene oxide sterilization and analysis of sterilization residues (EO and ECH). Price includes a 6-hour sterilization cycle for one euro pallet (80x120x190cm) with 3 extractions. Please ask for a quote for your medical device.

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 compounds (VOCs). Our experts are happy to help with any questions related to the tests and prepare a quote for you. Contact us with your testing needs through the form below, and we will get back to you shortly.

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.

Cytotoxicity assessment is a crucial part of biocompatibility testing, which ensures that medical devices do not cause adverse reactions when in contact with the body. The assessment is required for new medical devices to be approved in the EU (under the MDR) and the US (510(k) submission to the FDA). During cytotoxicity testing, the material's potential to damage or kill cells is assessed using in vitro methods. This involves exposing cultured cells to the material and observing any negative effects on cell health and viability. According to ISO 10993-5, cytotoxicity testing can be performed on an extract of the test material or the material itself, depending on the device type. The standard also lists several direct and indirect test methods. We can provide cytotoxicity tests using the methods outlined below. Direct methods: Neutral red uptake (NRU) method, MTT method, XTT method. Indirect methods: Filter diffusion, Agar diffusion. The displayed example price covers testing with the commonly used NRU method, performed under GLP. Please ask for a quote for your medical device.

Hemocompatibility testing is performed to evaluate the interaction between a medical device or material and blood. The goal is to ensure that the device does not cause adverse effects, such as clot formation, red blood cell damage (hemolysis), platelet activation, or immune responses. Regulatory bodies in the EU and the US (under MDR and FDA rules, respectively) require a hemocompatibility evaluation for all medical devices that come into direct or indirect contact with blood.  Measurlabs offers several hemocompatibility tests using methods outlined in the ISO 10993-4 standard: Hemolysis testing with direct and indirect methods to evaluate the device’s potential to cause damage to red blood cells, leading to hemolysis and the release of hemoglobin. Hemolysis testing is mandatory for all blood-contacting devices, regardless of whether contact is direct or indirect., Complement activation testing to measure the material’s tendency to activate the complement system, which is a key part of the immune response., Thrombogenicity testing to assess the material’s potential to promote thrombus (clot) formation. Available methods include the platelet and leukocyte count and the partial thromboplastin time (PTT) tests., Coagulation tests to determine whether the device or material interferes with the blood clotting process., Platelet activation testing to evaluate the materials’ propensity to induce platelet activation, which is an early step in clot formation., Hematology tests to assess the device’s impact on the number and proportion of blood components, including red and white blood cells, platelets, and leukocytes. . The example price includes hemolysis testing using either the direct or indirect (extract-based) method, performed under GLP (Good Laboratory Practice) principles. The extent of required testing depends on the device's classification, type of blood contact (direct or indirect), target market, and overall risk assessment. Please contact us for a detailed quotation tailored to your device or material.

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).

Pyrogenicity assessment by ISO 10993-11 to evaluate the material-mediated pyrogenic (i.e., fever-inducing) potential of medical devices. Material-mediated pyrogenicity tests focus on non-endotoxin-related substances, including bacterial exotoxins, endogenous pyrogens, prostaglandin, neurotransmitters, and metal salts. These can be studied using in vitro assays, where the fever-inducing potential is evaluated using cells, or in vivo rabbit pyrogen tests, where the animal's body temperature is monitored upon exposure to device extracts. Measurlabs provides testing using the following methods: Material-mediated pyrogenicity - In vivo (rabbit), Material-mediated pyrogenicity - In vitro (MAT, Monocyte Activation Test). Please ask for a quote for your medical device. We also offer Bacterial endotoxin tests (ISO 11737-3) to evaluate endotoxin-related pyrogenicity.

Sensitization assessment by ISO 10993-10 is a crucial part of biocompatibility testing and one of the most common tests required to ensure the safety and compliance of medical devices. The goal is to show that medical devices do not cause skin sensitization, such as allergic responses or immunological reactions, when in contact with the body. A sensitization assessment is required for new medical devices to be approved in the EU (under the MDR) and the USA (510(k) submission to the FDA). Sensitization tests can be performed on the material, the device itself, or an extract, depending on the device and test method type. ISO 10993-10 lists several in vitro and in vivo assays to assess the sensitization potential of medical devices and chemicals extracted from them. In vitro assays evaluate the skin sensitization potential by detecting chemical reactions or cell responses to the chemicals. Conversely, in vivo assays expose animals to the test sample or extract, which is typically applied by induction and challenge phases. Sensitization potential is then evaluated by observing possible reactions to the exposure. The sensitization reaction to the medical device is scored based on the evaluation criteria defined in ISO 10993-10. We can provide sensitization tests using several methods. A few examples are outlined below. In vivo methods: Guinea pig maximization test (GPMT), Closed-patch test (Buehler), Murine local lymph node assay (LLNA). In vitro methods: ARE-Nrf2 Luciferase test, Direct peptide reactivity assay (DPRA). The displayed example price covers testing with the commonly used GPMT method for liquid medical devices, performed under GLP. Please ask for a quote for your medical device.

As part of a medical device's biocompatibility evaluation, systemic toxicity tests following ISO 10993-11 assess the risk of the device or its components causing harmful effects throughout the body. Systemic toxicity refers to effects that may be observed when the device or its particles enter the body and affect multiple organs or systems, rather than a specific contact site. Systemic toxicity can be evaluated through studies of: Acute systemic toxicity (exposure up to 24 hours), Subacute systemic toxicity (exposure >24 hours up to 28 days), Subchronic systemic toxicity (exposure for part of the lifespan), Chronic systemic toxicity (exposure for a major part of the lifespan). The most appropriate study type depends on factors like administration route, exposure time, and frequency, which should be justified according to the device's intended use. All the tests are typically in vivo animal studies, and samples should be prepared following ISO 10993-12. Implantation studies may be combined with systemic toxicity testing, ask more about the possibilities from our expert. In toxicity studies, the tested device or its extract is administered or injected into the animal via the most clinically relevant route (dermal, implantation, inhalation, intradermal, intramuscular, intraperitoneal, intravenous, oral, or subcutaneous administration). Exposed animals are then evaluated through clinical pathology, histopathology, and/or gross pathology. Acute systemic toxicity tests assess the effects of single, multiple, or continuous exposures up to 24 hours and are often conducted on rodents (mice, rats)., Subacute, subchronic, and chronic systemic toxicity are relevant when the device is expected to be in contact with the body for prolonged periods, and testing is typically conducted on rats or rabbits.. Contact us to request a quote for a study tailored to your device.