ASTM F602-98a
(Guide)Standard Criteria for Implantable Thermoset Epoxy Plastics
Standard Criteria for Implantable Thermoset Epoxy Plastics
SCOPE
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.
General Information
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Standards Content (Sample)
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 602 – 98a
Standard Criteria for
Implantable Thermoset Epoxy Plastics
This standard is issued under the fixed designation F 602; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
1.1 These criteria cover thermoset plastics based on digly-
cidyl ethers of bisphenol A (DGEBPA) and appropriate curing
2. Referenced Documents
agents or catalysts as opposed to thermoplastics based on
2.1 ASTM Standards:
epoxy structures.
D 149 Test Method for Dielectric Breakdown Voltage and
1.2 These criteria are generic and are intended to provide
Dielectric Strength of Solid Electrical Insulating Materials
definitions and a standard description of epoxy plastics used in
at Commercial Power Frequencies
implantable devices. It is also intended to serve as a standard
D 150 Test Methods for A-C Loss Characteristics and
guide for the preparation of more specific documents with
Permittivity (Dielectric Constant) of Solid Electrical Insu-
values and limits covering specific end uses.
lating Materials
1.3 Compliance with these criteria shall not be construed as
D 257 Test Methods for D-C Resistance or Conductance of
an endorsement of implantability. The biocompatibility of
Insulating Materials
epoxy plastics as a class has not been established. Epoxy
D 570 Test Method for Water Absorption of Plastics
plastic is a generic term relating to the class of polymers
D 621 Test Methods for Deformation of Plastics Under
formed from epoxy resins, certain curing agents or catalysts,
Load
and various additives. Since many compositions and formula-
D 638 Test Method for Tensile Properties of Plastics
tions fall under this class, it is essential that the formulator or
D 785 Test Method for Rockwell Hardness of Plastics and
fabricator ensure biocompatibility of the specific composition
Electrical Insulating Materials
or formulation in its intended end use. Since these criteria
D 792 Test Methods for Specific Gravity (Relative Density)
provide guidance for the preparation of more specific docu-
and Density of Plastics by Displacement
ments covering specific end uses, these documents will provide
D 883 Terminology Relating to Plastics
bases for standardized evaluation of biocompatibility appropri-
D 952 Test Method for Bond or Cohesive Strength of Sheet
ate for a specific end use.
Plastics and Electrical Insulating Materials
1.4 Each of the properties listed shall be considered in
D 1042 Test Method for Linear Dimensional Changes of
selecting materials for specific end uses. A list of selected
Plastics
properties with limiting values assigned is suggested for
D 1434 Test Method for Determining Gas Permeability
separate product specifications.
Characteristics of Plastic Film and Sheeting
1.5 All of the properties and test methods listed may not be
D 1763 Specification for Epoxy Resins
pertinent in any specific situation, nor may all of the tests
D 2393 Test Method for Viscosity of Epoxy Resins and
outlined be required.
Related Components
1.6 These criteria are limited to functionally or fully cured
D 2471 Test Method for Gel Time and Peak Exothermic
epoxy plastics. Uncured or incompletely cured formulations
Temperature of Reacting Thermosetting Resins
are specifically excluded.
D 2562 Practice for Classifying Visual Defects in Parts
1.7 The epoxy plastics covered by this standard are those to
Molded from Reinforced Thermosetting Plastics
be evaluated for use in implantable biomedical devices. The
D 2566 Test Method for Linear Shrinkage of Cured Ther-
term implantable is herein considered to include devices used
mosetting Casting Resins During Cure
in vivo for time periods in excess of 30 days.
D 2734 Test Method for Void Content of Reinforced Plas-
1.8 This standard does not purport to address all of the
tics
safety concerns, if any, associated with its use. It is the
D 2990 Test Method for Tensile, Compressive, and Flexural
responsibility of the user of this standard to establish appro-
Creep and Creep Rupture of Plastics
These criteria are under the jurisdiction of ASTM Committee F-4 on Medical
and Surgical Materials and Devices and are the direct responsibility of Subcommit- Annual Book of ASTM Standards, Vol 10.01.
tee F04.11 on Polymeric Materials. Annual Book of ASTM Standards, Vol 08.01.
Current edition approved October 10, 1998. Published December 1998. Origi- Annual Book of ASTM Standards, Vol 15.09.
nally published as F 602 – 78. Last previous edition F 602 – 98. Annual Book of ASTM Standards, Vol 08.02.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 602
D 3013 Specification for Epoxy Molding Compounds 3.1.4 epoxy—oxirane ring structures.
D 3137 Test Method for Rubber Property—Hydrolytic Sta- O
bility R—CH—CH
E 96 Test Methods for Water Vapor Transmission of Mate- 3.1.4.1 epoxy plastic—thermoplastic or thermosetting plas-
rials tics containing ether or hydroxyalkyl repeating units or both,
F 74 Practice for Determining Hydrolytic Stability of Plas- resulting from the ring-opening reactions of lower molecular
tic Encapsulants for Electronic Devices weight polyfunctional oxirane resins or compounds, with
F 619 Practice for Extraction of Medical Plastics catalysts or with various polyfunctional acidic or basic core-
F 748 Practice for Selecting Generic Biological Test Meth- actants.
ods for Materials and Devices 3.1.4.2 epoxy resin—generally, any resin (liquid or solid)
2.2 AAM1 Standard: with a chemical structure at least difunctional in oxirane.
EOS-D 10/75 Standard for Ethylene Oxide Sterilization Specifically for this standard, the diglycidyl ethers of bisphenol
A or the equivalent. These compounds are defined as Grade 1
3. Terminology
in Specification D 1763.
3.1.5 Terms Relating to Cure:
3.1 Definitions:
3.1.1 accelerator—an additive used to increase the rate of 3.1.5.1 cure, v—to change the properties of a polymeric
system into a final, more stable, usable condition by the use of
cure. An accelerator may also be a catalyst, or it may actually
change composition and, therefore, not qualify as a catalyst. heat, radiation, or reaction with chemical additives.
3.1.5.2 cure cycle—the schedule of time periods at specified
3.1.2 additive—a chemical added to epoxy resins or hard-
conditions to which a reacting thermosetting material is sub-
eners to modify the handling characteristics or cured proper-
ties, or both, of the epoxy-hardener combination. jected to reach a specified property level.
3.1.5.3 cure time—the interval of time from the start of
3.1.2.1 diluent—a chemical used in admixture to modify or
enhance the properties of either or both the uncured or cured reaction to the time at which specified properties of the reacting
thermosetting composition are reached. For materials that react
formulations. A primary use is to reduce the viscosity of the
mixed system although other properties such as exotherm rate, under the conditions of mixing, the start of reaction is the time
of initial exposure to the conditions necessary for reaction to
stiffness, moisture absorption, etc., may be modified or en-
hanced also. occur.
3.1.5.4 functionally cured—the term used to denote an
3.1.2.1.1 nonreactive diluent—a diluent not containing
chemically reactive functional groups. epoxy plastic that has attained sufficient cure to achieve stable
properties.
3.1.2.1.2 reactive diluent—a diluent that reacts chemically
with the epoxy resin or hardener, or both, during cure. 3.1.5.5 fully cured—the term used to denote total disappear-
ance of epoxy groups as detected by infrared spectroscopy, or
3.1.2.2 filler—a relatively inert solid particulate material
added to an epoxy formulation to modify its strength, perma- other equally sensitive physicochemical methods.
3.1.5.6 one-component system—a formulation based on an
nence, working properties, or other qualities, or to lower costs.
3.1.3 curing agent or hardener—a compound normally epoxy resin preblended with a heat, moisture, or otherwise
activated curing agent or catalyst. The mixture is storable but
used in a predetermined concentration to react chemically
(copolymerize) by means of several different mechanisms (for cures under the appropriate activation conditions.
3.1.5.7 postcure—the additional and separate curing opera-
example, condensation or addition polymerization) with or
without heat or pressure in order to change its form from a tions to which a “hardened” thermosetting plastic composition
liquid or fusible, friable, soluble solid to an infusible, insoluble is subjected in order to enhance one or more properties. Also
used to ensure stabilization of physical properties under use
solid having useful and desirable application or end-use
properties. conditions.
3.1.5.8 two-component system—a formulation based on an
3.1.3.1 initiator—an additive used to cause a thermosetting
resin to react with itself (polymerize). Usually, these epoxy resin to which a curing agent or catalyst is added just
prior to use.
additives—used in relatively very small amounts—initiate
homo-polymerization of the epoxy resin resulting in ether
4. Chemical Composition
linkages.
4.1 Epoxy Resins—Oxirane-terminated reaction products of
NOTE 1—The
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