ASTM F641-09(2014)
Standard Specification for Implantable Epoxy Electronic Encapsulants
- Standard No.
- ASTM F641-09(2014)
- Release Date
- 2009
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F641-09(2023)
- Latest
- ASTM F641-09(2023)
- Scope
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 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 and health practices and determine the applicability of regulatory limitations prior to use.
ASTM F641-09(2014) 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*， 2024-04-20 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*， 2024-04-20 Update
- ASTM F135
- ASTM F602 Standard Criteria for Implantable Thermoset Epoxy Plastics
- ASTM F74
- 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(2014) history
- 2023 ASTM F641-09(2023) Standard Specification for Implantable Epoxy Electronic Encapsulants
- 2009 ASTM F641-09(2014) Standard Specification for Implantable Epoxy Electronic Encapsulants
- 2009 ASTM F641-09 Standard Specification for Implantable Epoxy Electronic Encapsulants
- 1998 ASTM F641-98a(2003) Standard Specification for Implantable Epoxy Electronic Encapsulants
- 1998 ASTM F641-98a Standard Specification for Implantable Epoxy Electronic Encapsulants
