Resistance to permeation by liquid chemicals according to EN 16523

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 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.

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.

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 that come into contact with skin, mucosal membranes, or subcutaneous tissues. Irritation tests performed according to the standard are commonly required to demonstrate compliance with EU MDR and FDA requirements with regard to biocompatibility. The appropriate testing approach is chosen based on the body contact site: Skin irritation tests evaluate whether the device or material causes localized skin irritation in 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 the material causes localized inflammatory responses in the dermis or subcutaneous layers.. The device itself is tested with a direct contact method, where 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. In vitro methods, such as the OECD 439 skin irritation test with a reconstructed human epidermis (RhE), are also available. For a more accurate quote, contact us through the form below 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.

Standard EN 228 outlines the testing requirements and methods for gasoline quality testing. The following tests are included in the package: Standard Parameter Requirements EN ISO 5164 RON Min. 95 EN ISO 5163 MON Min. 85 EN 237 Lead content Max. 5 mg/l EN ISO 12185 Density at 15 °C 720–775 kg/m3 EN ISO 20846 Sulfur content Max. 10 mg/kg EN 16136 Manganese content Max. 2 mg/l EN ISO 7536 Oxidation stability Min. 360 minutes EN ISO 6246 Washed gum content Max. 5 mg/100ml EN ISO 2160 Copper corrosion Class 1 ASTM D4176 Appearance Bright and clear EN ISO 22854 Hydrocarbon composition Benzene max. 1 v%, aromatics max. 35 v%, olefins max. 18 v%, oxygenates* EN 13016-1 Vapor pressure at 37.8 °C (DVPE) Depends on volatility class** EN ISO 3405 Distillation characteristics Final boiling point max. 210 °C, distillation residue max. 2 v%, evaporated volumes*** * For gasoline with max. 3.7 m% of oxygen, allowed oxygenate contents are methanol 3 v%, ethanol 10 v%, iso-propanol 12 v%, iso-butanol 15 v%, tert-butanol 15 v%, ethers with five or more carbon atoms 22 v%, and other oxygenates 15 v%. For gasoline with max. 2.7 m% of oxygen, allowed oxygenate contents are methanol 3 v% and ethanol 5 v%. ** For volatility class A: 45–60 kPa, B: 45–70 kPa, C: 50–80 kPa, D: 60–90 kPa, E: 65–95 kPa, and F: 70–100 kPa *** Percentage evaporated at 70 °C (E70): winter 22–50 v%, summer 22–48 v%, at 100 °C (E100): 46–71 v%, and at 150 °C (E150): min. 75 v%

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.

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.

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.