EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ASTM F641 testing. This standard covers thermoset plastics based on diglycidyl ethers of bisphenol A and amino functional curing agents or amine catalysts.
The epoxy encapsulators covered by this standard are intended to provide a tissue compatible protective coating for implantable medical devices such as pulse generators, telemetry devices and RF receivers. The biocompatibility of epoxy plastics has not been determined.
Epoxy plastic is a general term for a class of polymers made up of epoxy resins, certain curing agents or catalysts, and various additives.
Because many compositions and formulations fall into this category, it is important that the manufacturer ensure that the particular composition or formulation is implantable for its intended use with state-of-the-art testing methods available. This standard can be used as a basis for standardized assessment of biocompatibility for such implantable encapsulators.
This standard covers only the initial qualifications of epoxy encapsulators for implantable electronic circuits. Some of the requirements do not apply to routine lot-to-lot quality control.
Values stated in SI units should be accepted as standard. No other units of measurement are included in this standard.
This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and to determine the applicability of regulatory restrictions prior to use.
EUROLAB assists manufacturers with ASTM F641 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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