Evaluating the performance characteristics of health barrier products is important for both the practitioner and the patient. EUROLABoffers a unique combination of testing services to evaluate these properties for surgical gowns and drapes, as well as all types of surgical masks and general-use face masks to support marketing approvals and performance label claim verification. In addition, the laboratory offers medical respirator certification testing services for NIOSH applications.
For both disposable and reusable gowns, the barrier performance test must be completed on the final, finished, pre-shipment suit at the end of the garment's stated shelf life. If the gown is to be reusable, the barrier performance test should also be performed at the end of the labeled life cycle (maximum rework cycles).
EUROLABoffers barrier and non-barrier performance testing for surgical gowns and drapes according to AAMI PB70 and EN 13795. Testing requirements depend on gown or drape classification (Level 1, 2, 3 or 4), standard or high performance. EN 13795. This includes liquid, blood, viral and other barrier property assessments or physical properties:
These tests can be done for initial validation and product performance evaluation; however, continuous product monitoring should also be periodically reviewed and re-evaluated.
Medical manufacturers of medical masks and general use masks must follow ASTM F2100 (US submissions) and EN 14683 for CE marking (EU submissions). EUROLABoffers viable organism filtration efficiency studies (bacterial and viral, BFE/VFE), latex particle filtration efficiency studies (PFE), synthetic blood penetration for medical blood masks, differential pressure, flammability, microbial cleanliness and biocompatibility testing services.
Surgical masks are mostly worn to prevent particles from the wearer's mouth from coming into contact with others. Respirators have a tight fit and are used to protect the wearer from harmful particles that come into contact with them. To support medical mask or respirator manufacturers seeking NIOSH certification EUROLABProvides pre-certification testing to support manufacturer label claims and marketing approval submissions in accordance with 42 CFR Part 84. Services include inhalation/exhalation, sodium chloride (NaCl), and dioctyl phthalate. (DOP) filtration properties and valve leak tests.
For medical grade natural latex and synthetic glove manufacturers EUROLAB, evaluates glove leakage studies, viral penetration, tensile tests (aged and unaged), residual powder studies (aged and unaged), puncture resistance tests, and verification of physical dimensions. Latex (ELISA) tests are offered through a qualified third-party laboratory. US FDA glove custody studies and project support are also available for glove manufacturers.
Many of the tests developed for masks and gowns can be used to evaluate other flat stock filter materials and closed containment filters. Additional barrier performance studies, including physical and private studies, are available upon request.
EUROLAB, with its highly expert team and internationally accredited laboratories, Protective Barriers and Material Performance Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
