ASTM F1579-02

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

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.

General Information

• Status: Historical
• Publication Date: 09-Apr-2002
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Relations

• Replaces: ASTM F1579-98 - Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications
• Effective Date: 10-Apr-2002
• Replaced By: ASTM F1579-02e1 - Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications (Withdrawn 2011)
• 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 superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1579 – 02
Standard Specification for
Polyaryletherketone (PAEK) Polymers for Surgical Implant
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Applications
This standard is issued under the fixed designation F 1579; 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.
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1. Scope Commercial Power Frequencies
D 256 Test Methods for Determining the Izod Pendulum
1.1 This specification covers polyaryletherketone (PAEK)
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Impact Resistance of Plastics
polymers in virgin forms as supplied by a vendor (pellets,
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D 570 Test Method for Water Absorption of Plastics
powder, and so forth). It provides requirements and associated
D 621 Test Methods for Deformation of Plastics Under
test methods for these thermoplastics when they are to be used
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Load
in the manufacture of intracorporeal devices such as surgical
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D 638 Test Method for Tensile Properties of Plastics
implants or components of surgical or dental devices.
D 648 Test Method for Deflection Temperature of Plastics
1.2 As with any material, some characteristics may be
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Under Flexural Load
altered by the processing techniques (molding, extrusion,
D 695 Test Method for Compressive Properties of Rigid
machining, assembly, sterilization, and so forth) required for
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Plastics
the production of a specific part or device. Therefore, proper-
D 696 Test Method for Coefficient of Linear Thermal Ex-
ties of fabricated forms of these polymers should be evaluated
pansion of Plastics Between −30°C and 30°C with a
using test methods that are appropriate to ensure safety and
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Vitreous Silica Dilatometer
efficacy as agreed upon by the vendor, purchaser, and regulat-
D 790 Test Methods for Flexural Properties of Unreinforced
ing bodies.
and Reinforced Plastics and Electrical Insulating Materi-
1.3 The properties included in this specification are those
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als
applicable for PAEK polymers only. Fabricated forms, material
D 792 Test Methods for Specific Gravity (Relative Density)
or forms containing colorants, fillers, processing aids, or other
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and Density of Plastics by Displacement
additives, as well as polymer blends that contain PAEK, are not
D 955 Test Method for Measuring Shrinkage from Mold
covered by this specification.
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Dimensions of Thermoplastics
1.4 This specification is designed to recommend physical,
D 1238 Test Method for Flow Rates of Thermoplastics by
chemical, and biological test methods to establish a reasonable
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Extrusion Plastometer
level of confidence concerning the performance of unfilled
D 1505 Test Method for Density of Plastics by the Density-
PAEK polymers for use in medical devices. The properties
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Gradient Technique
listed should be considered in selecting material according to
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D 1898 Practice for Sampling of Plastics
the specific end-use requirements.
D 3417 Test Method for Heats of Fusion and Crystallization
1.5 When evaluating material to this specification hazardous
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of Polymers by Differential Scanning Calorimeter (DSC)
materials, operations, and equipment may be involved. This
D 3418 Test Methods for Transition Temperatures of Poly-
standard does not purport to address all of the safety concerns,
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mers by Differential Scanning Calorimeter (DSC)
if any, associated with its use. It is the responsibility of the user
D 4000 Classification System for Specifying Plastic Mate-
of this standard to establish appropriate safety and health
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rials
practices and determine the applicability of regulatory limita-
F 748 Practice for Selecting Generic Biological Test Meth-
tions prior to use.
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ods for Materials and Devices
2. Referenced Documents
F 1876 Specification for Polyetherketoneetherketoneketone
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(PEKEKK) Resins for Surgical Implant Applications
2.1 ASTM Standards:
F 2026 Specification for Polyetheretherketone (PEEK)
D 149 Test Methods for Dielectric Breakdown Voltage and
Dielectric Strength of Electrical Insulating Materials at
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Annual Book of ASTM Standards, Vol 10.01.
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This specification is under the jurisdiction of ASTM Committee F04 on Annual Book of ASTM Standards, Vol 08.01.
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Medical and Surgical Materials and Devicesand is under the direct responsibility of Discontinued; see 1993 Annual Book of ASTM Standards, Vol 08.01.
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Subcommittee F04.11on Polymeric Materials. Discontinued; see 1997 Annual Book of ASTM Standards, Vol 08.02.
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Current edition approved Apr. 10, 2002. Published June 2002. Originally Annual Book of ASTM Standards, Vol 08.03.
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published as F 1579 – 95. Last previous edition F 1579 – 98. Annual Book of ASTM Standards, Vol 13.01.
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