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ASTM F 641 : 2009 : R2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Specification for Implantable Epoxy Electronic Encapsulants
Available format(s)

Hardcopy , PDF

Superseded date

01-14-2023

Language(s)

English

Published date

11-27-2014

This specification covers thermoset plastics based on diglycidyl ethers of bisphenol A and amino functional curing agents or amine catalysts.

1.1This specification covers thermoset plastics based on diglycidyl ethers of bisphenol A and amino functional curing agents or amine catalysts.

1.2The 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.

1.3The encapsulants covered by this specification are for use in devices intended as long-term implants.

1.4Limitations—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.

1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6This 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.

Committee
F 04
DocumentType
Standard
Pages
4
ProductNote
Reconfirmed 2014
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products

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ASTM D 1434 : 1982 : R1998 Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
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