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1.1 These criteria cover thermoset plastics based on diglycidyl ethers of bisphenol A (DGEBPA) and appropriate curing agents or catalysts as opposed to thermoplastics based on epoxy structures.
1.2 These criteria are generic and are intended to provide definitions and a standard description of epoxy plastics used in implantable devices. It is also intended to serve as a standard guide for the preparation of more specific documents with values and limits covering specific end uses.
1.3 Compliance with these criteria shall not be construed as an endorsement of implantability. The biocompatibility of epoxy plastics as a class 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 class, it is essential that the formulator or fabricator ensure biocompatibility of the specific composition or formulation in its intended end use. Since these criteria provide guidance for the preparation of more specific documents covering specific end uses, these documents will provide bases for standardized evaluation of biocompatibility appropriate for a specific end use.
1.4 Each of the properties listed shall be considered in selecting materials for specific end uses. A list of selected properties with limiting values assigned is suggested for separate product specifications.
1.5 All of the properties and test methods listed may not be pertinent in any specific situation, nor may all of the tests outlined be required.
1.6 These criteria are limited to functionally or fully cured epoxy plastics. Uncured or incompletely cured formulations are specifically excluded.
1.7 The epoxy plastics covered by this standard are those to be evaluated for use in implantable biomedical devices. The term implantable is herein considered to include devices used in vivo for time periods in excess of 30 days.
1.8 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D149 Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at Commercial Power Frequencies
D150 Test Methods for AC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulation
D257 Test Methods for DC Resistance or Conductance of Insulating Materials
D570 Test Method for Water Absorption of Plastics
D621 Specification for Jute Rove and Plied Yarn for Electrical and Packing Purposes
D638 Test Method for Tensile Properties of Plastics
D785 Test Method for Rockwell Hardness of Plastics and Electrical Insulating Materials
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D952 Test Method for Bond or Cohesive Strength of Sheet Plastics and Electrical Insulating Materials
D1042 Test Method for Linear Dimensional Changes of Plastics Under Accelerated Service Conditions
D1434 Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
D1763 Specification for Epoxy Resins
D2393 Test Method for Viscosity of Epoxy Resins and Related Components
D2471 Practice for Gel Time and Peak Exothermic Temperature of Reacting Thermosetting Resins
D2562 Practice for Classifying Visual Defects in Parts Molded from Reinforced Thermosetting Plastics
D2734 Test Methods for Void Content of Reinforced Plastics
D3137 Test Method for Rubber Property--Hydrolytic Stability
E96/E96M Test Methods for Water Vapor Transmission of Materials
F74 Practice for Determining Hydrolytic Stability of Plastic Encapsulants for Electronic Devices
F619 Practice for Extraction of Medical Plastics
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
AAM1 StandardEOS-D 10/75 Standard for Ethylene Oxide Sterilization Available from the Association for the Advancement of Medical Instrumentation, 1901 N. Ft. Myer Dr., Suite 602, Arlington, VA 22209.
ISO StandardISO10993 Biological Evaluation of Medical Devices Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 13101900(Thermoset plastics)