ASTM F 641 REV A Standard Specification for Implantable Epoxy Electronic Encapsulants
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ASTM F 641 REV A Document Information:
Title
Standard Specification for Implantable Epoxy Electronic Encapsulants
ASTM International
Publication Date:
Oct 10, 1998
Scope:
This specification covers thermoset plastics based on diglycidyl
ethers of bisphenol A and amino
functional curing agents or amine catalysts.
The epoxy encapsulants covered by this specification are intended to
provide a tissue-compatible
protective covering for implantable medical devices such as pulse
generators, telemetry devices and
RF receivers. The biocompatibility of epoxy plastics has not been
established. Epoxy plastic is a
generic term relating to the class of polymers formed from epoxy
resins, certain curing agents or
catalysts and various additives. Since many compositions and
formulations fall under this category,
it is essential that the fabricator assure safety of implantability of
the specific composition or
formulation for the intended use by current state-of-the-art test
methods. This specification can
be used as a basis for standardized evaluation of biocompatibility for
such implantable
encapsulants.
The encapsulants covered by this specification are for use in devices
intended as long-term
implants.
Limitations - This specification covers only the initial qualification
of epoxy encapsulants for
implantable electronic circuitry. Some of the requirements are not
applicable to routine lot to lot
quality control.
This standard does not purport to address all of the safety concerns,
if any, associated with its
use. It is the responsibility of the user of this standard to
establish appropriate safety and
health practices and determine the applicability of regulatory
limitations prior to use.
Keywords:
- encapsulants
- evaluation of biocompatibility
- implantable medical devices
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