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ASTM F641-09

(Specification)

Standard Specification for Implantable Epoxy Electronic Encapsulants

Standard Specification for Implantable Epoxy Electronic Encapsulants

ABSTRACT
This specification covers thermoset plastics based on diglycidyl ethers of bisphenol A and amino functional curing agents or amine catalysts for implantable epoxy electronic encapsulants. Encapsulants shall be classified depending on contact with tissues or physiological fluids. Chemical composition requirements may include additives, phthalate esters, amines, catalysts, and carbonates. The material shall be tested for the following physical properties: peak exotherm temperature, transparency, foreign particles, USP biological test plastic containers, USP pyrogen test, sterilant residues, cure shrinkage, embedment stress, tissue culture test, long-term immersion test, and accelerated immersion test. The material shall also be inspected with infrared spectroscopy, amine number, epoxide equivalent weight, spectrographic analysis, and total nitrogen.
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.

General Information

Status
Historical
Publication Date
31-Jul-2009
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.11 - Polymeric Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F641-98a(2003) - Standard Specification for Implantable Epoxy Electronic Encapsulants
Effective Date
01-Aug-2009
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
01-Aug-2009

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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F641 −09
StandardSpecification for
1
Implantable Epoxy Electronic Encapsulants
ThisstandardisissuedunderthefixeddesignationF641;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
1.1 This specification covers thermoset plastics based on 2.1 ASTM Standards:
diglycidyl ethers of bisphenol A and amino functional curing D149Test Method for Dielectric Breakdown Voltage and
agents or amine catalysts. DielectricStrengthofSolidElectricalInsulatingMaterials
at Commercial Power Frequencies
1.2 The epoxy encapsulants covered by this specification
D150Test Methods forAC Loss Characteristics and Permit-
areintendedtoprovideatissue-compatibleprotectivecovering
tivity (Dielectric Constant) of Solid Electrical Insulation
for implantable medical devices such as pulse generators,
D257Test Methods for DC Resistance or Conductance of
telemetry devices and RF receivers. The biocompatibility of
Insulating Materials
epoxy plastics has not been established. Epoxy plastic is a
D570Test Method for Water Absorption of Plastics
generic term relating to the class of polymers formed from
D638Test Method for Tensile Properties of Plastics
epoxy resins, certain curing agents or catalysts and various
D790Test Methods for Flexural Properties of Unreinforced
additives. Since many compositions and formulations fall
and Reinforced Plastics and Electrical Insulating Materi-
under this category, it is essential that the fabricator assure
als
safety of implantability of the specific composition or formu-
D1042Test Method for Linear Dimensional Changes of
lation for the intended use by current state-of-the-art test
Plastics Under Accelerated Service Conditions
methods. This specification can be used as a basis for stan-
D1239Test Method for Resistance of Plastic Films to
dardized evaluation of biocompatibility for such implantable
Extraction by Chemicals
encapsulants.
D1434TestMethodforDeterminingGasPermeabilityChar-
1.3 The encapsulants covered by this specification are for
acteristics of Plastic Film and Sheeting
use in devices intended as long-term implants.
D2240TestMethodforRubberProperty—DurometerHard-
1.4 Limitations—This specification covers only the initial ness
D2471PracticeforGelTimeandPeakExothermicTempera-
qualification of epoxy encapsulants for implantable electronic
3
circuitry. Some of the requirements are not applicable to tureofReactingThermosettingResins(Withdrawn2008)
D2562Practice for Classifying Visual Defects in Parts
routine lot-to-lot quality control.
Molded from Reinforced Thermosetting Plastics
1.5 The values stated in SI units are to be regarded as
D2566Test Method for Linear Shrinkage of CuredThermo-
standard. No other units of measurement are included in this
3
setting Casting Resins During Cure (Withdrawn 1993)
standard.
D2734TestMethodsforVoidContentofReinforcedPlastics
1.6 This standard does not purport to address all of the
D3137Test Method for Rubber Property—Hydrolytic Sta-
safety concerns, if any, associated with its use. It is the
bility
responsibility of the user of this standard to establish appro-
F74Practice for Determining Hydrolytic Stability of Plastic
priate safety and health practices and determine the applica- 3
Encapsulants for Electronic Devices (Withdrawn 1994)
bility of regulatory limitations prior to use.
1 2
This specification is under the jurisdiction of ASTM Committee F04 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical and Surgical Materials and Devices and is the direct responsibility of contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Subcommittee 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 1979. Last previous edition approved in 2003 as F641–98a(2003). The last approved version of this historical standard is referenced on
DOI: 10.1520/F0641-09. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F641−09
F135TestMethodforEmbedmentStressCausedbyCasting 5. Physical Properties
Compounds on Glass-Encased Electronic (Withdrawn
5.1 Type I Encapsulants:
3
1997)
5.1.1 Peak Exotherm Temperature (Test Method D2471)—
F602Criteria for Implantable Thermoset Epoxy Plastics
The peak exotherm temperature during cure shall be kept
F748PracticeforSelectingGenericBiologicalTestMethods
below the maximum acceptable value for the lowes
...

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:F641–98a (Reapproved 2003) Designation: F 641 – 09
Standard Specification for
1
Implantable Epoxy Electronic Encapsulants
This standard is issued under the fixed designation F 641; 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 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—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.
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
D 638 Test Method for Tensile Properties of Plastics
D 790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
3
D883Terminology Relating to Plastics 1042
D1042 Test Method for Linear Dimensional Changes of Plastics Under Accelerated Service Conditions
D 1239 Test Method for Resistance of Plastic Films to Extraction by Chemicals
D 1434 Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
3
D1763Specification for Epoxy Resins 2240
D1898Practice for Sampling of Plastics
D2240 Test Method for Rubber Property—Durometer Hardness
D 2471 Test Method Practice for Gel Time and Peak Exothermic Temperature of Reacting Thermosetting Resins
D 2562 Practice for Classifying Visual Defects in Parts Molded from Reinforced Thermosetting Plastics
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.11 on Polymeric Materials.
Current edition approved Apr. 10, 2003. Published May 2003. Originally approved in 1979. Last previous edition approved in 1998 as F641–98a.
Current edition approved Aug. 1, 2009. Published September 2009. Originally approved in 1979. Last previous edition approved in 2003 as F 641 – 98a(2003).
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 10.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

-----------------
...

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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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