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ASTM F3333-20

(Specification)

Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

SCOPE
1.1 This specification covers chopped carbon-fiber reinforced (CFR) polyetheretherketone (PEEK) polymer in pellets, filaments used in additive manufacturing, or fabricated forms. It provides requirements and associated test methods for these thermoplastic composites when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices.  
1.2 The properties included in this specification are those applicable for chopped CFR-PEEK compounds and fabricated forms only. Materials or forms containing colorants, fillers other than carbon fibers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification.  
1.2.1 This standard does not include continuous carbon-fiber reinforced PEEK composites, which are fabricated using a different process than chopped CFR-PEEK.  
1.2.2 This standard can include CFR-PEEK compounds that are fabricated with the use of coupling (sizing) agents. However, when coupling agents are used to improve wetting of the carbon fibers, the biological risk assessments and biocompatibility testing should consider these coupling agents.  
1.3 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of CFR-PEEK polymers for use in medical implant devices.  
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 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved.  
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.

General Information

Status
Published
Publication Date
14-Nov-2020
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

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ASTM F3333-20 - Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant ApplicationsASTM F3333-20 - Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
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ASTM F3333-20 - Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
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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.
Designation: F3333 −20
Standard Specification for
Chopped Carbon Fiber Reinforced (CFR)
Polyetheretherketone (PEEK) Polymers for Surgical Implant
1
Applications
This standard is issued under the fixed designation F3333; 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 responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
1.1 This specification covers chopped carbon-fiber rein-
mine the applicability of regulatory limitations prior to use.
forced (CFR) polyetheretherketone (PEEK) polymer in pellets,
filaments used in additive manufacturing, or fabricated forms. 1.7 This international standard was developed in accor-
It provides requirements and associated test methods for these dance with internationally recognized principles on standard-
thermoplastic composites when they are to be used in the
ization established in the Decision on Principles for the
manufacture of intracorporeal devices such as surgical im-
Development of International Standards, Guides and Recom-
plants or components of surgical or dental devices.
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.2 The properties included in this specification are those
applicable for chopped CFR-PEEK compounds and fabricated
2. Referenced Documents
forms only. Materials or forms containing colorants, fillers
2
other than carbon fibers, processing aids, or other additives, as
2.1 ASTM Standards:
well as polymer blends which contain PEEK, or reclaimed
D256 Test Methods for Determining the Izod Pendulum
materials, are not covered by this specification.
Impact Resistance of Plastics
1.2.1 This standard does not include continuous carbon-
D638 Test Method for Tensile Properties of Plastics
fiber reinforced PEEK composites, which are fabricated using
D648 Test Method for Deflection Temperature of Plastics
a different process than chopped CFR-PEEK.
Under Flexural Load in the Edgewise Position
1.2.2 ThisstandardcanincludeCFR-PEEKcompoundsthat
D695 Test Method for Compressive Properties of Rigid
are fabricated with the use of coupling (sizing) agents.
Plastics
However,whencouplingagentsareusedtoimprovewettingof
D790 Test Methods for Flexural Properties of Unreinforced
the carbon fibers, the biological risk assessments and biocom-
and Reinforced Plastics and Electrical Insulating Materi-
patibility testing should consider these coupling agents.
als
1.3 This specification is designed to recommend physical,
D792 Test Methods for Density and Specific Gravity (Rela-
chemical, and biological test methods to establish a reasonable
tive Density) of Plastics by Displacement
level of confidence concerning the performance of CFR-PEEK
D1505 Test Method for Density of Plastics by the Density-
polymers for use in medical implant devices.
Gradient Technique
1.4 The values stated in SI units are to be regarded as
D4000 Classification System for Specifying Plastic Materi-
standard. No other units of measurement are included in this
als
standard.
E1994 Practice for Use of Process Oriented AOQL and
LTPD Sampling Plans
1.5 When evaluating material in accordance with this
specification, hazardous materials, operations, and equipment F748 PracticeforSelectingGenericBiologicalTestMethods
may be involved. for Materials and Devices
F2026 Specification for Polyetheretherketone (PEEK) Poly-
1.6 This standard does not purport to address all of the
mers for Surgical Implant Applications
safety concerns, if any, associated with its use. It is the
1
This specification is under the jurisdiction of ASTM Committee F04 on
2
Medical and Surgical Materials and Devices and is the direct responsibility of For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Subcommittee F04.11 on Polymeric Materials. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Nov. 15, 2020. Published November 2020. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F3333-20. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3333 − 20
3
2.2 ISO Standards: 4.2 The structure of the chopped carbon fiber is character-
ISO 178 Plastics—Determination of Flexural Properties ized by its route of manufacture (for examp
...

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

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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.  
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1.5 The values stated in SI units are to be regarded as the standard.  
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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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1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
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.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
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 ...

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