Medical electrical equipment testing by IEC 60601-1

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.

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.

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).

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.

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 1-200 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 reprocessing 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.

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.

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.

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).