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ASTM F 641 : 2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

11-11-2014

Language(s)

English

Published date

08-01-2009

CONTAINED IN VOL. 13.01, 2015 Describes thermoset plastics based on diglycidyl ethers of bisphenol A and amino functional curing agents or amine catalysts.

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

1.2 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.

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

1.4 LimitationsThis 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.

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

1.6 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.

Committee
F 04
DocumentType
Standard
Pages
4
ProductNote
Reconfirmed 2009
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM D 2471 : 1999 Standard Test Method for Gel Time and Peak Exothermic Temperature of Reacting Thermosetting Resins (Withdrawn 2008)
ASTM F 74 : 1973 : R1989 Practice for Determining Hydrolytic Stability of Plastic Encapsulants for Electronic Devices (Withdrawn 1994)
ASTM D 1239 : 2014 : REDLINE Standard Test Method for Resistance of Plastic Films to Extraction by Chemicals
ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
ASTM D 2734 : 2016 : REDLINE Standard Test Methods for Void Content of Reinforced Plastics
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM D 3137 : 1981 : R2018 Standard Test Method for Rubber Property—Hydrolytic Stability
ASTM D 257 : 2014 : REDLINE Standard Test Methods for DC Resistance or Conductance of Insulating Materials
ASTM D 570 : 1998 : R2018 Standard Test Method for Water Absorption of Plastics
ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
ASTM D 2562 : 1994 Standard Practice for Classifying Visual Defects in Parts Molded from Reinforced Thermosetting Plastics

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