ASTM F602-98a(2003)
(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.
1.7 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.
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Designation:F 602–98a (Reapproved 2003)
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 1.8 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 These criteria cover thermoset plastics based on digly-
responsibility of the user of this standard to establish appro-
cidyl ethers of bisphenol A (DGEBPA) and appropriate curing
priate safety and health practices and determine the applica-
agents or catalysts as opposed to thermoplastics based on
bility of regulatory limitations prior to use.
epoxy structures.
1.2 These criteria are generic and are intended to provide
2. Referenced Documents
definitions and a standard description of epoxy plastics used in
2.1 ASTM Standards:
implantable devices. It is also intended to serve as a standard
D 149 Test Method for Dielectric Breakdown Voltage and
guide for the preparation of more specific documents with
Dielectric Strength of Solid Electrical Insulating Materials
values and limits covering specific end uses.
at Commercial Power Frequencies
1.3 Compliance with these criteria shall not be construed as
D 150 Test Methods for ac Loss Characteristics and Permit-
an endorsement of implantability. The biocompatibility of
tivity (Dielectric Constant) of Solid Electrical Insulating
epoxy plastics as a class has not been established. Epoxy
Materials
plastic is a generic term relating to the class of polymers
D 257 Test Methods for dc Resistance or Conductance of
formed from epoxy resins, certain curing agents or catalysts,
Insulating Materials
and various additives. Since many compositions and formula-
D 570 Test Method for Water Absorption of Plastics
tions fall under this class, it is essential that the formulator or
D 621 Test Methods for Deformation of Plastics Under
fabricator ensure biocompatibility of the specific composition
Load
or formulation in its intended end use. Since these criteria
D 638 Test Method for Tensile Properties of Plastics
provide guidance for the preparation of more specific docu-
D 785 Test Method for Rockwell Hardness of Plastics and
mentscoveringspecificenduses,thesedocumentswillprovide
Electrical Insulating Materials
bases for standardized evaluation of biocompatibility appropri-
D 792 TestMethodsforDensityandSpecificGravity(Rela-
ate for a specific end use.
tive Density) of Plastics by Displacement
1.4 Each of the properties listed shall be considered in
D 883 Terminology Relating to Plastics
selecting materials for specific end uses. A list of selected
D 952 Test Method for Bond or Cohesive Strength of Sheet
properties with limiting values assigned is suggested for
Plastics and Electrical Insulating Materials
separate product specifications.
D 1042 Test Method for Linear Dimensional Changes of
1.5 All of the properties and test methods listed may not be
Plastics Under Accelerated Service Conditions
pertinent in any specific situation, nor may all of the tests
D 1434 Test Method for Determining Gas Permeability
outlined be required.
Characteristics of Plastic Film and Sheeting
1.6 These criteria are limited to functionally or fully cured
D 1763 Specification for Epoxy Resins
epoxy plastics. Uncured or incompletely cured formulations
D 2393 Test Method for Viscosity of Epoxy Resins and
are specifically excluded.
Related Components
1.7 The epoxy plastics covered by this standard are those to
D 2471 Test Method for Gel Time and Peak Exothermic
be evaluated for use in implantable biomedical devices. The
Temperature of Reacting Thermosetting Resins
term implantable is herein considered to include devices used
D 2562 Practice for Classifying Visual Defects in Parts
in vivo for time periods in excess of 30 days.
Annual Book of ASTM Standards, Vol 10.01.
1 3
These criteria are under the jurisdiction of ASTM Committee F04 on Medical Annual Book of ASTM Standards, Vol 08.01.
and Surgical Materials and Devices and are the direct responsibility of Subcommit- Discontinued; See 1994 Annual Book of ASTM Standards, Vol 08.01.
tee F04.11 on Polymeric Materials. Annual Book of ASTM Standards, Vol 15.09.
Current edition approved Apr. 10, 2003. Published May 2003. Originally Discontinued; See 1995 Annual Book of ASTM Standards, Vol 08.02.
approved in 1978. Last previous edition approved in 1998 as F 602 – 98a. Annual Book of ASTM Standards, Vol 08.02.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 602–98a (2003)
Molded from Reinforced Thermosetting Plastics additives—used in relatively very small amounts—initiate
D 2566 Test Method for Linear Shrinkage of Cured Ther- homo-polymerization of the epoxy resin resulting in ether
mosetting Casting Resins During Cure linkages.
D 2734 Test Method for Void Content of Reinforced Plas-
NOTE 1—The term “catalyst” is frequently misused to denote any
tics
material added to a resin to cause a reaction to occur. This usage should
D 2990 Test Method forTensile, Compressive, and Flexural
be discouraged. The Society of Plastics Industries defines a catalyst as “a
Creep and Creep Rupture of Plastics
compound which alters the speed of a reaction without changing its
D 3013 Specification for Epoxy Molding Compounds original composition.”
D 3137 Test Method for Rubber Property—Hydrolytic Sta-
3.1.4 epoxy—oxirane ring structures.
bility
O
E 96 Test Methods for Water Vapor Transmission of Mate-
R—CH—CH
10 2
rials
3.1.4.1 epoxy plastic—thermoplastic or thermosetting plas-
F 74 Practice for Determining Hydrolytic Stability of Plas-
tics containing ether or hydroxyalkyl repeating units or both,
tic Encapsulants for Electronic Devices
resulting from the ring-opening reactions of lower molecular
F 619 Practice for Extraction of Medical Plastics
weight polyfunctional oxirane resins or compounds, with
F 748 Practice for Selecting Generic Biological Test Meth-
catalysts or with various polyfunctional acidic or basic core-
ods for Materials and Devices
actants.
2.2 AAM1 Standard:
13 3.1.4.2 epoxy resin—generally, any resin (liquid or solid)
EOS-D 10/75 Standard for Ethylene Oxide Sterilization
with a chemical structure at least difunctional in oxirane.
Specificallyforthisstandard,thediglycidylethersofbisphenol
3. Terminology
A or the equivalent. These compounds are defined as Grade 1
3.1 Definitions:
in Specification D 1763.
3.1.1 accelerator—an additive used to increase the rate of
3.1.5 Terms Relating to Cure:
cure. An accelerator may also be a catalyst, or it may actually
3.1.5.1 cure, v—to change the properties of a polymeric
change composition and, therefore, not qualify as a catalyst.
system into a final, more stable, usable condition by the use of
3.1.2 additive—a chemical added to epoxy resins or hard-
heat, radiation, or reaction with chemical additives.
eners to modify the handling characteristics or cured proper-
3.1.5.2 cure cycle—the schedule of time periods at specified
ties, or both, of the epoxy-hardener combination.
conditions to which a reacting thermosetting material is sub-
3.1.2.1 diluent—a chemical used in admixture to modify or
jected to reach a specified property level.
enhance the properties of either or both the uncured or cured
formulations. A primary use is to reduce the viscosity of the 3.1.5.3 cure time—the interval of time from the start of
reactiontothetimeatwhichspecifiedpropertiesofthereacting
mixed system although other properties such as exotherm rate,
thermosetting composition are reached. For materials that react
stiffness, moisture absorption, and so forth, may be modified or
under the conditions of mixing, the start of reaction is the time
enhanced also.
of initial exposure to the conditions necessary for reaction to
3.1.2.1.1 nonreactive diluent—a diluent not containing
occur.
chemically reactive functional groups.
3.1.2.1.2 reactive diluent—a diluent that reacts chemically 3.1.5.4 functionally cured—the term used to denote an
with the epoxy resin or hardener, or both, during cure. epoxy plastic that has attained sufficient cure to achieve stable
3.1.2.2 filler—a relatively inert solid particulate material properties.
added to an epoxy formulation to modify its strength, perma-
3.1.5.5 fully cured—the term used to denote total disappear-
nence, working properties, or other qualities, or to lower costs.
ance of epoxy groups as detected by infrared spectroscopy, or
3.1.3 curing agent or hardener—a compound normally
other equally sensitive physicochemical methods.
used in a predetermined concentration to react chemically
3.1.5.6 one-component system—a formulation based on an
(copolymerize) by means of several different mechanisms (for
epoxy resin preblended with a heat, moisture, or otherwise
example, condensation or addition polymerization) with or
activated curing agent or catalyst. The mixture is storable but
without heat or pressure in order to change its form from a
cures under the appropriate activation conditions.
liquid or fusible, friable, soluble solid to an infusible, insoluble
3.1.5.7 postcure—the additional and separate curing opera-
solid having useful and desirable application or end-use
tions to which a “hardened” thermosetting plastic composition
properties.
is subjected in
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