EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ASTM F1984 testing. This standard provides a protocol for rapid, in vitro screening for all complementary activating properties of solid materials used in the manufacture of medical devices for blood contact.
This application aims to evaluate the acute in vitro full complement activating properties of solid materials intended for use in contact with blood. For this application, the words "serum" and "supplement" are used interchangeably (most biological supply companies use these words synonymously with serum used as a source of supplements).
This application consists of two procedural parts. Procedure A describes exposing solids to a standard batch of human serum using a 0.1 mL serum/13 x 100 mm disposable test tube. Cellulose acetate powders and fibers are used as samples of test materials. Procedure B describes testing exposed serum for significant functional complete complement depletion compared to control samples.
This application does not address the function, elaboration, or depletion of individual complement components, nor does it address the use of plasma as a source of complement.
This application is one of the few applications developed for the evaluation of the biocompatibility of materials. Application F748 can provide guidance for the selection of appropriate methods for testing materials for other aspects of biocompatibility.
Values stated in SI units should be accepted as standard. No other units of measurement are included in this standard.
EUROLAB assists manufacturers with ASTM F1984 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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