Laura Ahola

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 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.

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