ASTM F1579-02e1

Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications (Withdrawn 2011)

ABSTRACT
This specification covers polyaryletherketone (PAEK) polymers in virgin forms as supplied by a vendor (pellets, powder, and so forth). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices. The described PAEK polymers are pure semicrystalline homopolymers consisting of phenylene rings connected by ether and carbonyl groups. The tensile strength, elongation, and impact strength shall be tested to meet the requirements prescribed.
SCOPE
1.1 This specification covers polyaryletherketone (PAEK) polymers in virgin forms as supplied by a vendor (pellets, powder, and so forth). It provides requirements and associated test methods for these thermoplastics 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 As with any material, some characteristics may be altered by the processing techniques (molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of these polymers should be evaluated using test methods that are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies.
1.3 The properties included in this specification are those applicable for PAEK polymers only. Fabricated forms, material or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends that contain PAEK, are not covered by this specification.
1.4 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of unfilled PAEK polymers for use in medical devices. The properties listed should be considered in selecting material according to the specific end-use requirements.
1.5 When evaluating material to this specification hazardous materials, operations, and equipment may be involved.  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.
WITHDRAWN RATIONALE
This specification covers polyaryletherketone (PAEK) polymers in virgin forms as supplied by a vendor (pellets, powder, and so forth). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices.  
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in January 2011 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

• Status: Withdrawn
• Publication Date: 09-Apr-2002
• Withdrawal Date: 31-Dec-2010
• 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

Relations

• Replaces: ASTM F1579-02 - Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications
• Effective Date: 10-Apr-2002
• 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-2002

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
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Designation: F1579 – 02
Standard Specification for
Polyaryletherketone (PAEK) Polymers for Surgical Implant
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Applications
This standard is issued under the fixed designation F1579; 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.
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´ NOTE—Editorial changes were made throughout in June 2003.
1. Scope 2. Referenced Documents
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1.1 This specification covers polyaryletherketone (PAEK) 2.1 ASTM Standards:
polymers in virgin forms as supplied by a vendor (pellets, D149 Test Method for Dielectric Breakdown Voltage and
powder, and so forth). It provides requirements and associated Dielectric Strength of Solid Electrical Insulating Materials
test methods for these thermoplastics when they are to be used at Commercial Power Frequencies
in the manufacture of intracorporeal devices such as surgical D256 Test Methods for Determining the Izod Pendulum
implants or components of surgical or dental devices. Impact Resistance of Plastics
1.2 As with any material, some characteristics may be D570 Test Method for Water Absorption of Plastics
altered by the processing techniques (molding, extrusion, D621 TestMethodsforDeformationofPlasticsUnderLoad
machining, assembly, sterilization, and so forth) required for D638 Test Method for Tensile Properties of Plastics
the production of a specific part or device. Therefore, proper- D648 Test Method for Deflection Temperature of Plastics
ties of fabricated forms of these polymers should be evaluated Under Flexural Load in the Edgewise Position
using test methods that are appropriate to ensure safety and D695 Test Method for Compressive Properties of Rigid
efficacy as agreed upon by the vendor, purchaser, and regulat- Plastics
ing bodies. D696 Test Method for Coefficient of Linear Thermal Ex-
1.3 The properties included in this specification are those pansion of Plastics Between Ø30°C and 30°C with a
applicableforPAEKpolymersonly.Fabricatedforms,material Vitreous Silica Dilatometer
or forms containing colorants, fillers, processing aids, or other D790 Test Methods for Flexural Properties of Unreinforced
additives,aswellaspolymerblendsthatcontainPAEK,arenot and Reinforced Plastics and Electrical Insulating Materials
covered by this specification. D792 Test Methods for Density and Specific Gravity (Rela-
1.4 This specification is designed to recommend physical, tive Density) of Plastics by Displacement
chemical, and biological test methods to establish a reasonable D955 Test Method of Measuring Shrinkage from Mold
level of confidence concerning the performance of unfilled Dimensions of Thermoplastics
PAEK polymers for use in medical devices. The properties D1238 Test Method for Melt Flow Rates of Thermoplastics
listed should be considered in selecting material according to by Extrusion Plastometer
the specific end-use requirements. D1505 Test Method for Density of Plastics by the Density-
1.5 Whenevaluatingmaterialtothisspecificationhazardous Gradient Technique
materials, operations, and equipment may be involved. This D1898 Practice for Sampling of Plastics
standard does not purport to address all of the safety concerns, D3417 Test Method for Enthalpies of Fusion and Crystal-
if any, associated with its use. It is the responsibility of the user lization of Polymers by Differential Scanning Calorimetry
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of this standard to establish appropriate safety and health (DSC)
practices and determine the applicability of regulatory limita- D3418 Test Method for Transition Temperatures and En-
tions prior to use. thalpies of Fusion and Crystallization of Polymers by
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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 under the direct responsibility of contact ASTM Customer Service at [e-mail]. 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 Apr. 10, 2002. Published June 2002. Originally the ASTM website.
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published as F1579 – 95. Last previous edition F1579 – 98. DOI: 10.1520/F1579- Withdrawn. The last approved version of this historical standard is referenced
02E01. on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F1579 – 02
Differential Scanning Calorimetry 4. Classification
D4000 Classification System for Specifying Plastic Materi-
4.1 PAEK polymers in the scope of this specification
...