Laboratory testing of medical devices

The NRU assay is a quantitative test to determine the potential biological reactivity of a mammalian cell culture in response to a medical device extract. It is described in Annex A of ISO 10993-5 and is one of the most commonly used methods for medical device cytotoxicity testing. The test item is extracted in cell culture medium, which is suitable for both polar and non-polar extracts. The cells are exposed to the extract, and their viability is assessed after staining with neutral red (NR) solution. The number of viable cells correlates with the color intensity determined by photometric measurements, as non-viable cells do not absorb NR. The medical device is considered non-cytotoxic if the percentage of viable cells is ≥ 70 % of the untreated control.

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.

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.

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.

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.

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.

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 according to 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 substances actually released by the medical device during clinical use (leachables). 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 based on the device's composition, intended contact time, and contact site. Any chemicals detected above concentrations established to be safe require further evaluation, typically through a toxicological risk assessment (ISO 10993-17). We provide a range of chemical characterization tests customized to the product, the intended market area (MDR, FDA), and applicable quality requirements (GLP, accreditation). Please contact us for a custom quotation.

The MTT assay is a quantitative study to determine the potential biological reactivity of a mammalian cell culture in response to a medical device extract. It is one of the in vitro methods outlined in standard ISO 10993-5 for evaluating the cytotoxicity of medical devices. For the assay, the test item is extracted in cell culture medium, and the cells are grown in tissue culture plates and exposed to the test item extract. The plates are incubated, after which cell viability is assessed by measuring the conversion of the yellow MTT by the mitochondrial reductase enzymes into blue-violet insoluble formazan.  As only viable cells convert MTT into formazan, the number of viable cells correlates with the color intensity of the resulting cell culture, which is determined by photometric measurements. The medical device is considered non-cytotoxic if 70% or more of the cells are viable when compared to a control sample.

MEM elution is a qualitative study to determine the cytotoxic properties of medical devices. It is often performed together with a quantitative test, such as the MTT or XTT assay. In the test, mammalian fibroblast cells are grown in a serum-supplemented minimum essential medium (MEM). Once the cells have been cultured, medical device extracts are introduced. After incubation, the overall health of the cells is visually observed under a light microscope and assigned a grade between 0 and 4, based on the extent of cellular damage. Grade 3 (moderate reactivity) or greater is considered a cytotoxic effect.

ISO 10993-17 provides a structured approach to establishing safe exposure levels for chemicals released by medical devices during clinical use. A toxicological risk assessment in accordance with the standard is typically required if extractable and leachable substances are discovered during chemical characterization (ISO 10993-18) in concentrations above the analytical evaluation threshold (AET). A comprehensive risk assessment is created using toxicological data from existing literature, or mathematical tools when data on particular substances are unavailable.  The 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 includes the evaluation of one extractable chemical and the reporting fee. Typically, multiple substances are evaluated during the risk assessment, but the price per substance is significantly lower for additional chemicals. The extent of the required toxicological evaluation depends on the results of the ISO 10993-18 chemical characterization, which we can also offer if not yet completed. Contact our experts using the form below to get a tailored quote.

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.

The purpose of this study is to determine the potential hemolytic activity (i.e., ability to cause damage to red blood cells) of a medical device and its extracts. As recommended by the ASTM F756 standard, the device is tested in parallel for indirect and direct contact, which means that both the device and its extracts are brought into contact with blood during testing. However, one of these exposure routes can be excluded if the choice is justified by the device’s intended use. Hemolytic potential is assessed by measuring the amount of free plasma hemoglobin in blood after exposure to the test article. Elevated levels indicate a hemolytic effect.

Bacterial endotoxin tests, also known as Limulus Amebocyte Lysate (LAL) tests, are used to detect endotoxins in pharmaceuticals to evaluate the pyrogenic potential of the material, especially for batch release. Endotoxins are components of gram-negative bacteria that are common contaminants in manufacturing processes. Several methods can be used to detect and quantify bacterial endotoxins: Kinetic turbidimetric assay, Chromogenic method, Kinetic chromogenic assay , Gel-clot method. The displayed price includes one routine LAL assay for one sample with a chromogenic method, performed according to USP <85> or EP 2.6.14 (Ph. Eur 2.6.14). Method validation may be required before routine testing is commenced, and this will be priced separately. We can also offer custom bacterial endotoxin test packages tailored to your needs, especially for large sample volumes. Please ask for more information and 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

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) 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). The analysis package covers the following substances Substance CAS N:o Abbreviation Hexamethylcyclotrisiloxane 541-05-9 D3 Octamethylcyclotetrasiloxane 556-67-2 D4 Decamethylcyclopentasiloxane 541-02-6 D5 Dodecamethylcyclohexasiloxane 540-97-6 D6 Tetradecamethylcycloheptasiloxane 107-50-6 D7 Hexadecamethylcyclooctasiloxane 556-68-3 D8 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 chemico assessment of skin sensitization potential using the direct peptide reactivity assay (DPRA) according to OECD Test Guideline 442C. The assay is mentioned in Annex C of ISO 10993-10 as a potential alternative to in vivo sensitization tests, such as the guinea pig maximization test (GPMT) and the Buehler test. Medical devices are tested with two solvents (one polar and one non-polar), and extraction is performed in duplicate (2 independent extractions per device per solvent). The extracts are incubated separately with cysteine- and lysine-containing synthetic peptides for 24 hours at 25 ± 2.5°C. After incubation, the remaining peptide concentration is measured by HPLC with UV detection at 220 nm, and the percentage depletion of each peptide is calculated. Results are interpreted using the prediction model defined in OECD TG 442C: a mean depletion above 6.38% indicates skin sensitization potential, with reactivity further classified as minimal, low, moderate, or high.

ASTM D4169 outlines test methods to simulate the stresses that shipping containers may encounter during handling, storage, and transportation. The standard is typically followed in the medical device industry to evaluate the ability of the outer packaging to protect the sterile barrier system (SBS), which in turn protects the enclosed device from microbial contamination. Some of the key tests covered by ASTM D4169 include: Drop testing, Vehicle stacking, Vibration testing, Pressure testing, Concentrated impact, Climatic conditioning. We are happy to prepare a custom offer for distribution testing, accounting for your packaging system's expected distribution environment, level of protection required, and the modes of transport used (air, land, and sea). Do not hesitate to request a quote using the form below.

Particulate contamination testing of orthopedic implants according to ISO 19227 and AAMI TIR42 to support cleaning process validation for in-process and final cleaning. Ten samples are tested per validation run, alongside blank control samples to correct for background contamination. Particles are counted and classified into three size categories: 25–50 µm, 51–100 µm, >100 µm. A contamination index is calculated by applying weighting coefficients to each size class — 0.1, 0.2, and 5, respectively — to reflect the increasing biological significance of larger particles. The weighted particle counts from the test samples and blank controls are summed separately, and the blank-corrected contamination index is derived by subtracting the blank contribution from the sample result. The acceptance criterion is based on the limits for infusion sets for medical use defined in DIN EN ISO 8536-4. The contamination index must not exceed 90. Please contact us to discuss sample submission requirements and whether your implant type falls within the scope of the validated method.

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.

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.

Medical devices sterilized with ethylene oxide are tested according to ISO 10993-7 to ensure that residual chemical concentrations are not high enough to make normal product use unsafe. Testing is required for the regulatory approval of applicable devices in the EU (under the MDR) and the US (510(k) submission to the FDA). Ethylene oxide can be used when steam sterilization is not appropriate for the device. ISO 10993-7 sets maximum daily doses for ethylene oxide (EO) and ethylene chlorohydrin (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 EO and ECH 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 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.

In vitro identification of chemicals not requiring classification for eye irritation or serious eye damage, using the EpiOcular™ Eye Irritation Test (EIT) according to OECD Test Guideline 492. The method uses a reconstructed human cornea-like epithelium (RhCE) tissue construct that closely mimics the histological and physiological properties of the human corneal epithelium, and serves as a non-animal alternative to the in vivo rabbit eye test (OECD 405). The test substance is applied topically to the RhCE tissue. Following exposure and a post-treatment incubation period, tissue viability is measured by the MTT assay and expressed as a percentage of the negative control. A substance is identified as not requiring classification (UN GHS No Category) if tissue viability exceeds 60%. Substances that reduce viability below this threshold are considered to require classification, but the method cannot differentiate between UN GHS Category 1 (serious eye damage) and Category 2 (eye irritation) — further testing is required to make that distinction. OECD TG 492 is accepted for eye irritation and serious eye damage hazard assessment under REACH (Annex VII/VIII information requirements) and the EU Biocidal Products Regulation (Regulation (EU) No 528/2012, Annex II core data set). It is also mentioned alongside other in vitro OECD methods in the latest version of ISO 10993-23 standard on medical device irritation tests, although it is noted that several in vitro tests in a tiered testing strategy may be needed to replace the in vivo OECD 405 test.

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.

Wound dressings are applied to open wounds acquired through trauma or surgery to absorb excess wound exudate, and to protect the wound from further mechanical damage and infection. Appropriate testing of different types of wound dressings, including gauzes, hydrogels, films, foam dressings, and hydrocolloid dressings, is required for approval both in the European Union (MDR) and the United States (510(k) submission to the FDA). The EN 13726 standard contains test methods to assess important characteristics of wound dressings including absorption, moisture transmission rate of permeable film wound and fixation dressings, waterproofness, and extensibility. These methods are conducted in vitro, and involve testing the dressing materials under different physical and chemical parameters. We currently offer the following tests under EN 13726: Annex B and C - Free swell absorptive capacity and fluid retention, Annex D - Absorption under compression, Annex E and O - Fluid handling capacity with air expulsion, Annex F - Fluid donation of amorphous hydrogel dressings, Annex G - Dispersion characteristics of gelling dressings, Annex H and I - Moisture vapor transmission rate of wound dressings, Annex J - Waterproofness, Annex K - Extensibility and permanent set.

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.

Determination of barrier materials' resistance to permeation by liquid chemicals under continuous contact according to EN 16523-1. The test uses a permeation cell in which the test material separates the challenge chemical from a collecting medium on the inner side. The collecting medium is sampled and analyzed quantitatively over time to generate a permeation curve from which the primary outcome, the normalized breakthrough time (NBT), is derived. Permeation rates (including steady‑state and normalization values) are also reported in µg·cm⁻²·min⁻¹. EN 16523-1 is used in conjunction with product-specific standards that define pre-conditioning, sampling, and performance levels – for example, EN 374-1 for protective gloves. Degradation testing is covered separately by standards such as EN 374-4.

We have various testing services available for ultrapure water. Pricing depends on the selected parameters and the number of samples. Please contact Measurlabs to get an offer. Note that we will provide suitable shipping containers based on the analyses that are ordered. Trace elements by ICP-MS For the determination of elemental impurities, we offer a basic 36-element and an extended 67-element package. The basic package includes the following 36 elements: Li, Be, B, Na, Mg, Al, K, Ca, Ti, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, Ga, Ge, As, Sr, Zr, Nb, Mo, Ag, Cd, Sn, Sb, Ba, Ta, W, Pt, Au, Tl, Pb, and Bi. The extended analysis includes the following elements in addition to the basic package: Ce, Cs, Dy, Er, Eu, Gd, Hf, Ho, In, Ir, La, Lu, Hg, Nd, Os, Pd, Pr, Re, Rh, Rb, Ru, Sm, Sc, Se, Te, Tb, Th, Tm, U, Yb, and Y. Reporting limits depend on the element and specific sample matrix, but typically vary between 0.001 ppb and 0.6 ppb. For this analysis, samples must be delivered in Teflon containers. Hardness Hardness value can be calculated based on the ICP-MS results. Silicon and silica (Si, SiO2) Our service catalog includes the determination of total, dissolved, and colloidal silica (SiO2). Total silicon is analyzed using the ICP-OES technique, and dissolved silicon by UV-VIS (molybdenum heteropoly blue method). Colloidal silica is calculated as the difference between total silica and dissolved silica. Total organic and inorganic carbon (TOC and TIC) We offer TOC determination for ultrapure water samples with a 5 ppb quantification limit. For this analysis, samples must be delivered in certified 40 ml TOC vials. Total inorganic carbon (TIC) analysis can also be performed using a TOC analyzer. Anions by ion chromatography (IC) For anions, we have a basic package and a separate package for organic anions. The basic package includes the following anions: bromide(Br⁻), chloride (Cl⁻), fluoride (F⁻), nitrate (NO₃⁻), nitrite (NO₂⁻), phosphate (PO₄³⁻), and sulfate (SO₄²⁻). Analysis of organic anions includes: acetate, formate, glycolate, propionate, and butyrate. Reporting limits depend on the anion and sample matrix, but typically vary between 0.02 and 1 ppb for basic anions and are around 25 ppb for organic anions. For this analysis, samples must be delivered in HDPE bottles. Cations by ion chromatography (IC) The analysis package for cations includes the determination of the following cations: ammonium (NH4+), calcium (Ca2+), lithium (Li+), magnesium (Mg2+), potassium (K+), and sodium (Na+). Reporting limits typically vary between 2 ppb and 5 ppb. Samples must be delivered in HDPE bottles. PFAS compounds (24 compounds) Analysis includes PFOS, PFOA, PFNA, PFHxS, and 20 other selected PFAS compounds. The complete list of compounds can be provided upon request. The reporting limit is typically 1 ng/L. The sample must be delivered in a plastic PFAS-free bottle, preferably made from HDPE.

ASTM F1980 establishes a standardized approach for accelerated aging of medical device sterile barrier systems (SBS), either with or without devices. Accelerated aging studies help manufacturers assess the shelf life of the product more rapidly than real-time aging studies. The results may be used as a preliminary indication of the product’s stability and packaging integrity until real-time aging results become available. This approach aligns with regulatory expectations, including FDA guidance (21 CFR - Process Validation) and ISO 11607-1. In accelerated aging studies, materials are exposed to elevated temperatures for a shorter period, simulating the effects of real-time aging. Based on the results, manufacturers can estimate how long the packaging will maintain its protective properties under real-world storage and transportation conditions. Product stability can be evaluated both upon completion and throughout the aging process using various methods. The assessed properties are selected based on the manufacturer’s specific requirements and regulatory considerations, and they may include the following: Sterility, Mechanical performance (e.g., shear, tensile, and compression strength), Chemical properties (e.g., product degradation). Measurlabs can provide accelerated and real-time aging in parallel. We can also help with stability and integrity testing during and after the aging period. Do not hesitate to contact us for a custom quote tailored to your project.

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 a comprehensive range of 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 hemoglobin release. 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 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.

The mouse lymphoma assay (OECD 490) is an in vitro method for studying the potential mutagenicity of medical devices on mammalian cells. Together with the Ames test, it is an FDA-recommended method for assessing the genotoxic potential of medical devices under ISO 10993-3. In MLA, mouse cell lines are exposed to the extract of the test item in the presence and absence of metabolic activation. The cells are then presented to the selectively cytotoxic agent trifluorothymidine. Only mutated cells survive the exposure and form colonies, whereas normal cells do not. An increased number of colonies compared to the negative controls indicates potential mutagenicity. Measurlabs can support medical device manufacturers with the full genotoxicity evaluation. Please get in touch with our experts for a quote.

The ISO 11737-3 standard provides internationally recognized guidelines for bacterial endotoxin testing of medical devices. Tests described in the standard can be used to evaluate the pyrogenic potential of medical devices for batch release and to validate manufacturing, cleaning, and sterilization processes in terms of their capacity to prevent endotoxin contamination. The Limulus Amebocyte Lysate (LAL) test is the most common approach to endotoxin testing. ISO 11737-3 describes several LAL methods, including kinetic turbidimetric and chromogenic techniques. One routine LAL assay for one sample with a chromogenic method is included in the displayed example price. We can also offer custom bacterial endotoxin test packages, especially for large sample volumes. Please describe your testing needs using the form below to get a quote for your samples.

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.

Quantitative 4-field carrier test determining the bactericidal and yeasticidal activity of disinfectant wipe systems according to EN 16615. Unlike suspension-based tests, the method explicitly incorporates mechanical wiping action, replicating real-world application to assess both microbial inactivation and the potential for cross-contamination across a surface. The method applies to pre-impregnated ready-to-use wipes and wipes wetted with disinfectant at the point of use. A non-porous carrier is divided into four fields, inoculated with test organisms (e.g., S. aureus, P. aeruginosa, E. hirae, C. albicans) and allowed to dry, then treated by a standardized wiping motion across successive fields. Surviving organisms are recovered and enumerated by culture-based viable counts (CFU), and results are expressed as log₁₀ reduction relative to controls. The test generates data for bactericidal and yeasticidal efficacy claims under EN 14885, which defines the test standards applicable to chemical disinfectants and antiseptics in the European market. Results can also be used to support Biocidal Products Regulation (Regulation (EU) No 528/2012) dossier submissions.

Cytotoxicity assessment is a crucial part of biocompatibility testing, which is performed to ensure that medical devices do not cause adverse reactions when in contact with the body. The assessment is required for practically all 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 listed below. Direct methods: Neutral red uptake (NRU) assay, MTT assay, XTT assay. 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.

ISO 10993-3 is an internationally recognized standard for evaluating the potential of medical devices and their components to cause irreversible genetic damage during clinical use. A genotoxicity assessment performed in accordance with the standard is generally required for devices that come into the following types of contact with the human body: Prolonged (>24 h to 30 d) or long-term (>30 d) contact with tissues, bone, or dentin, Long-term contact with mucosal membranes or breached surfaces, Long-term indirect contact with blood, Contact of any duration with circulating blood. The assessment includes a review of existing safety data, such as results from chemical characterization and toxicological studies. Testing is required if existing data do not adequately address all potential risks.  Genotoxicity tests evaluate the potential of the device to induce gene mutations or chromosomal damage. As a single test cannot detect all genotoxins, the evaluation should include at least two in vitro tests: A bacterial reverse mutation test (Ames) is typically performed first as a quick screening test., Another in vitro assay, such as the Mouse Lymphoma Assay (MLA) or the Mammalian Cell Micronucleus test (MNT), is then performed to capture genotoxic compounds not detected in the Ames test.. Further in vitro or in vivo tests, such as in vivo chromosomal aberration (OECD 473) or in vivo transgenic rodent mutagenicity (OECD 488) assays, may be required if genotoxic effects are observed in the initial two in vitro tests. Test selection depends on several factors, including device type, contact category, exposure duration, market area, and possible cytotoxicity of device extracts. Measurlabs provides both the genotoxicity tests listed above and expert support for drafting a testing plan. You can contact us using the form below to get a quote. Please note that the methods can also be adapted for other sample types, including pharmaceuticals, chemicals, and novel food ingredients.

Assessment of skin corrosion hazard using a reconstructed human epidermis (RhE) model according to OECD Test Guideline 431. The method determines whether a test substance is corrosive or non-corrosive and, where supported by the data, assigns UN GHS subcategories (1A, 1B, or 1C). RhE tissues are treated topically with the test substance under short and longer exposure conditions. Tissue viability is measured by the MTT assay, in which MTT is converted to formazan and quantified spectrophotometrically as percent viability relative to a negative control. For colored substances or substances that directly reduce MTT, HPLC/UPLC spectrophotometry is used to quantify the MTT formazan peak area and eliminate interference. Appropriate controls for non-specific MTT reduction and color interference are included where required. Results are reported as percent viability for each replicate and mean values across replicates, with coefficients of variation, and interpreted against the prediction model cut-offs defined in OECD TG 431. The test report states the hazard conclusion — corrosive or non-corrosive, with subcategory where applicable — alongside the supporting numerical data. Data generated under OECD 431 are accepted for UN GHS hazard classification and labeling, REACH dossier submissions under Commission Regulation (EC) No 440/2008, and EU CLP classification.

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).

IEC 60601-1 is a widely accepted benchmark standard that defines the general requirements for the safety of medical electrical equipment, particularly addressing the electromagnetic compatibility of such devices. The price for testing is variable and depends on the complexity of the medical device - please contact us to receive an offer.

Performance and safety testing of single-use gravity feed infusion sets for medical use according to ISO 8536-4. Measurlabs offers the following tests from the standard: Particulate contamination: Ten infusion sets are flushed with filtered distilled water under laminar flow conditions, and the eluate is vacuum filtered through a 0.45 µm membrane. Particles are counted microscopically and classified into three size categories (25–50 µm, 51–100 µm, and >100 µm, with respective weighting coefficients of 0.1, 0.2, and 5). A blank control is run simultaneously, and the blank-corrected contamination index must not exceed 90. Efficiency of the fluid filter: The fluid filter is tested using an aqueous suspension of latex particles (20 ± 1 µm diameter, approximately 1000 particles per 100 ml). The test suspension is passed through the filter, and the effluent is collected on a membrane filter. Retained latex particles are counted microscopically at ×50 to ×100 magnification across a minimum of 50% of the grid squares. The retention rate, calculated as the proportion of particles retained relative to the total particle count in the test fluid, must be at least 80%. Chemical tests on the extract: A test solution is prepared by circulating 250 ml of grade 1 or grade 2 water through three infusion sets for 2 hours at 37°C. A blank control solution is prepared identically without infusion sets. The solutions are tested for the following parameters: Reducing (oxidizable) matter: Titrimetric determination using potassium permanganate; the difference in Na₂S₂O₃ consumption between the test and blank solutions must not exceed 2.0 ml., Metal ions: Colorimetric assessment and/or AAS; total barium, chromium, copper, lead, and tin must not exceed 1 µg/ml, and cadmium must not exceed 0.1 µg/ml., Titration acidity or alkalinity: Titration with NaOH or HCl using Tashiro indicator; no more than 1 ml of either titrant shall be required to reach the grey endpoint., Residue on evaporation: Gravimetric determination after evaporation and drying at 105°C; total dry residue must not exceed 5 mg per 50 ml of extract., UV absorption: Scanning spectrophotometry from 250 to 320 nm relative to the blank; absorbance must be below 0.1 across the wavelength range.. For information on other tests described in ISO 8536-4, please contact our experts using the form below.

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.

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 according to 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 the device does 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 or 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 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 in 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 our experts for more information. 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 get a quote for a study tailored to your device.

The XTT assay is a quantitative test used to assess the potential cytotoxic effects of a medical device extract on mammalian cell cultures. It is one of the in vitro cytotoxicity methods described in ISO 10993-5. The test item is extracted in cell culture medium, and the cells are seeded in tissue culture plates and exposed to the extract. After incubation, cell viability is evaluated by photometrically measuring the enzymatic conversion of the XTT reagent into a soluble orange formazan dye. Because only viable cells reduce XTT, the amount of formazan formed directly reflects the number of metabolically active cells. A device is considered non-cytotoxic when cell viability is equal to or greater than 70% compared to an untreated control.