Testing services / Face mask tests according to EN 14683 for type II and type IIR masks

Face mask tests according to EN 14683 for type II and type IIR masks

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.

Suitable sample matrices: Surgical face masks
Required sample quantity: 70 Type II masks or 100 Type IIR masks
Typical turnaround time: 3 weeks after receiving the samples
Available quality systems: Accredited testing laboratory
Device types: Microbial cell counterStandard specific equipment
Standard: EN 14683 ISO 10993-10 ISO 10993-5 ISO 11737-1 ISO 22609
Method expert: Laura Ahola

Medical devices

Textiles and furniture

Biological testing

Microbiological analysis

Standardized product tests

Price

Typical price range (Excl. VAT):

3,809–4,245 €per sample

We also charge a 97 € service fee per order.

Large batches of samples are eligible for discounts.

Questions? We're happy to help.

info@measurlabs.com

Questions? We're happy to help.

info@measurlabs.com

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Other tests we offer

Bioburden testing according to ISO 11737-1, aerobic bacteria and fungi

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 5 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), Tests under GLP. 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.

Sterility tests according to ISO 11737-2: Aerobic bacteria, anaerobic bacteria and fungi

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

Skin sensitization testing according to ISO 10993-10

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.

Cytotoxicity testing according to ISO 10993-5

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 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.

Cleaning validation of medical devices according to ISO 17664

ANSI ST98, EN 11737-2, ISO 10993-1, …

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.

Irritation testing according to ISO 10993-23

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).

Antibacterial activity on plastic and non-porous surfaces according to ISO 22196

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.

1,249–1,856 €

Biocompatibility evaluation of breathing gas pathways according to ISO 18562

ISO 18562-2, ISO 18562-3

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.

Genotoxicity - Bacterial reverse mutation test (AMES)

ISO 10993-3, OECD 471

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.

Pyrogenicity testing by ISO 10993-11

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.

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