ASTM F602-09
(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.
1.8 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.
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Designation: F602 − 09
StandardCriteria for
1
Implantable Thermoset Epoxy Plastics
ThisstandardisissuedunderthefixeddesignationF602;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope term implantable is herein considered to include devices used
in vivo for time periods in excess of 30 days.
1.1 These criteria cover thermoset plastics based on digly-
1.8 This standard does not purport to address all of the
cidyl ethers of bisphenol A (DGEBPA) and appropriate curing
safety concerns, if any, associated with its use. It is the
agents or catalysts as opposed to thermoplastics based on
responsibility of the user of this standard to establish appro-
epoxy structures.
priate safety and health practices and determine the applica-
1.2 These criteria are generic and are intended to provide
bility of regulatory limitations prior to use.
definitions and a standard description of epoxy plastics used in
implantable devices. It is also intended to serve as a standard
2. Referenced Documents
guide for the preparation of more specific documents with
2
2.1 ASTM Standards:
values and limits covering specific end uses.
D149 Test Method for Dielectric Breakdown Voltage and
1.3 Compliance with these criteria shall not be construed as
DielectricStrengthofSolidElectricalInsulatingMaterials
an endorsement of implantability. The biocompatibility of
at Commercial Power Frequencies
epoxy plastics as a class has not been established. Epoxy
D150 Test Methods forAC Loss Characteristics and Permit-
plastic is a generic term relating to the class of polymers
tivity (Dielectric Constant) of Solid Electrical Insulation
formed from epoxy resins, certain curing agents or catalysts,
D257 Test Methods for DC Resistance or Conductance of
and various additives. Since many compositions and formula-
Insulating Materials
tions fall under this class, it is essential that the formulator or
D570 Test Method for Water Absorption of Plastics
fabricator ensure biocompatibility of the specific composition
D621 Specification for Jute Rove and Plied Yarn for Elec-
or formulation in its intended end use. Since these criteria
3
trical and Packing Purposes (Withdrawn 2000)
provide guidance for the preparation of more specific docu-
D638 Test Method for Tensile Properties of Plastics
mentscoveringspecificenduses,thesedocumentswillprovide
D785 Test Method for Rockwell Hardness of Plastics and
bases for standardized evaluation of biocompatibility appropri-
Electrical Insulating Materials
ate for a specific end use.
D792 Test Methods for Density and Specific Gravity (Rela-
1.4 Each of the properties listed shall be considered in
tive Density) of Plastics by Displacement
selecting materials for specific end uses. A list of selected
D952 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.
D1042 Test Method for Linear Dimensional Changes of
Plastics Under Accelerated Service Conditions
1.5 All of the properties and test methods listed may not be
D1434 TestMethodforDeterminingGasPermeabilityChar-
pertinent in any specific situation, nor may all of the tests
acteristics of Plastic Film and Sheeting
outlined be required.
D1763 Specification for Epoxy Resins
1.6 These criteria are limited to functionally or fully cured
D2393 Test Method for Viscosity of Epoxy Resins and
epoxy plastics. Uncured or incompletely cured formulations 3
Related Components (Withdrawn 1992)
are specifically excluded.
D2471 PracticeforGelTimeandPeakExothermicTempera-
3
1.7 The epoxy plastics covered by this standard are those to tureofReactingThermosettingResins(Withdrawn2008)
be evaluated for use in implantable biomedical devices. The
D2562 Practice for Classifying Visual Defects in Parts
1 2
These criteria are under the jurisdiction of ASTM Committee F04 on Medical For referenced ASTM standards, visit the ASTM website, www.astm.org, or
and Surgical Materials and Devicesand are the direct responsibility of Subcommit- contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
tee F04.11 on Polymeric Materials. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Aug. 1, 2009. Published September 2009. Originally the ASTM website.
3
approved in 1978. Last previous edition approved in 2003 as F602 – 98a(2003) . The last approved version of this historical standard is referenced on
DOI: 10.1520/F0602-09. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959.
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F602–98a (Reapproved 2003) Designation: F 602 – 09
Standard Criteria for
1
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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 These criteria cover thermoset plastics based on diglycidyl ethers of bisphenolA(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.Alist 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
2
2.1 ASTM Standards:
D 149 Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at
Commercial Power Frequencies
D 150 Test Methods for acAC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulating
2
Materials Insulation
D 257 Test Methods for dcDC Resistance or Conductance of Insulating Materials
D 570 Test Method for Water Absorption of Plastics
3
D 621 Test Methods for Deformation of Plastics Under Load
D 638 Test Method for Tensile Properties of Plastics
D 785 Test Method for Rockwell Hardness of Plastics and Electrical Insulating Materials
D 792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
3
D883Terminology Relating to Plastics
D 952 Test Method for Bond or Cohesive Strength of Sheet Plastics and Electrical Insulating Materials
1
These criteria are under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and are the direct responsibility of Subcommittee
F04.11 on Polymeric Materials.
Current edition approved Apr. 10, 2003. Published May 2003. Originally approved in 1978. Last previous edition approved in 1998 as F602–98a.
Current edition approved Aug. 1, 2009. Published September 2009. Originally approved in 1978. Last previous edition approved in 2003 as F 602 – 98a(2003) .
2
Annual Book of ASTM Standards, Vol 10.01.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
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