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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.

General Information

Status
Historical
Publication Date
09-Apr-2003
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 F602-98a - Standard Criteria for Implantable Thermoset Epoxy Plastics
Effective Date
10-Apr-2003
Replaced By
ASTM F602-09 - Standard Criteria for Implantable Thermoset Epoxy Plastics
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
10-Apr-2003
Referred By
ASTM F641-09(2023) - Standard Specification for Implantable Epoxy Electronic Encapsulants
Effective Date
10-Apr-2003

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ASTM F602-98a(2003) - Standard Criteria for Implantable Thermoset Epoxy PlasticsASTM F602-98a(2003) - Standard Criteria for Implantable Thermoset Epoxy Plastics
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ASTM F602-98a(2003) - Standard Criteria for Implantable Thermoset Epoxy Plastics
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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:F 602–98a (Reapproved 2003)
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 (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.
2
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
2
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,
2
Insulating Materials
and various additives. Since many compositions and formula-
3
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
4
Load
or formulation in its intended end use. Since these criteria
3
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
3
Electrical Insulating Materials
bases for standardized evaluation of biocompatibility appropri-
D 792 TestMethodsforDensityandSpecificGravity(Rela-
ate for a specific end use.
3
tive Density) of Plastics by Displacement
1.4 Each of the properties listed shall be considered in
3
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
3
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
3
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.
5
Characteristics of Plastic Film and Sheeting
1.6 These criteria are limited to functionally or fully cured
3
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.
6
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
7
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.
2
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.
4
and Surgical Materials and Devices and are the direct responsibility of Subcommit- Discontinued; See 1994 Annual Book of ASTM Standards, Vol 08.01.
5
tee F04.11 on Polymeric Materials. Annual Book of ASTM Standards, Vol 15.09.
6
Current edition approved Apr. 10, 2003. Published May 2003. Originally Discontinued; See 1995 Annual Book of ASTM Standards, Vol 08.02.
7
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
...

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SCOPE
1.1 This standard specifies a test method for determining the endurance properties and deformation, under specified laboratory conditions, of ultra high molecular weight polyethylene (UHMWPE) tibial bearing components used in bicompartmental or tricompartmental knee prosthesis designs.  
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SCOPE
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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.
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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.  
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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.  
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Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
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1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
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1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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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.

  • Guide
    8 pages
    English language
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  • Guide
    8 pages
    English language
    sale 15% off