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 ensure 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 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.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
ASTM F641-09(2023) Referenced Document
ASTM D1042 Standard Test Method for Linear Dimensional Changes of Plastics Under Accelerated Service Conditions
ASTM D1239 Standard Test Method for Resistance of Plastic Films to Extraction by Chemicals
ASTM D1434 Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
ASTM D149 Standard Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at Commercial Power Frequencies
ASTM D150 Standard Test Methods for AC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulation
ASTM D2240 Standard Test Method for Properties of Rubber &8212; Durometer Hardness*, 2024-04-22 Update
ASTM D2471 Standard Test Method for Gel Time and Peak Exothermic Temperature of Reacting Thermosetting Resins
ASTM D2562 Standard Practice for Classifying Visual Defects in Parts Molded from Reinforced Thermosetting Plastics
ASTM D2566 Test Method for Linear Shrinkage of Cured Thermosetting Casting Resins During Cure
ASTM D257 Standard Test Methods for DC Resistance or Conductance of Insulating Materials
ASTM D2734 Standard Test Methods for Void Content of Reinforced Plastics
ASTM D3137 Standard Test Method for Rubber Property—Hydrolytic Stability
ASTM D570 Standard Test Method for Water Absorption of Plastics
ASTM D638 Standard Test Method for Tensile Properties of Plastics
ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*, 2024-04-22 Update
ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
ASTM F641-09(2023) history
2023ASTM F641-09(2023) Standard Specification for Implantable Epoxy Electronic Encapsulants
2009ASTM F641-09(2014) Standard Specification for Implantable Epoxy Electronic Encapsulants
2009ASTM F641-09 Standard Specification for Implantable Epoxy Electronic Encapsulants
1998ASTM F641-98a(2003) Standard Specification for Implantable Epoxy Electronic Encapsulants
1998ASTM F641-98a Standard Specification for Implantable Epoxy Electronic Encapsulants