ASTM F2026-00
(Specification)Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
SCOPE
1.1 This specification covers polyetheretherketone (PEEK) polymer 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 which 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 PEEK polymers only. Indicated properties are for injection molded forms. Fabricated forms, material or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, 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 virgin PEEK polymers for use in medical implant devices. The properties listed should be considered in selecting material in accordance with the specific end-use requirements.
1.5 When evaluating material in accordance with 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.
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Designation: F 2026 – 00
Standard Specification for
Polyetheretherketone (PEEK) Resins for Surgical Implant
Applications
This standard is issued under the fixed designation F 2026; 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 at Commercial Power Frequencies
D 256 Test Method for Determining the Pendulum Impact
1.1 This specification covers polyetheretherketone (PEEK)
Resistance of Notched Specimens of Plastics
resins in virgin forms as supplied by a vendor (flakes, pellets,
D 570 Test Method for Water Absorption of Plastics
blocks, 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
Load
in the manufacture of intracorporal devices such as surgical
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
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
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 resins should be evaluated
pansion of Plastics Between −30C and 30C
using test methods which are appropriate to ensure safety and
D 790 Test Methods for Flexural Properties of Unreinforced
efficacy as agreed upon by the vendor, purchaser, and regulat-
and Reinforced Plastics and Electrical Insulating Materi-
ing bodies.
als
1.3 The properties included in this specification are those
D 792 Test Methods for Density and Specific Gravity Rela-
applicable for PEEK resins only. Fabricated forms, material or
tive Density) of Plastics by Displacement
forms containing colorants, fillers, processing aids, or other
D 955 Test Method for Measuring Shrinkage from Mold
additives, as well as polymer blends which contain PEEK, are
Dimensions of Molded Plastics
not covered by this specification.
D 1238 Test Method for Flow Rates of Thermoplastics by
1.4 This specification is designed to recommend physical,
Extrusion Plastometer
chemical, and biological test methods to establish a reasonable
D 1505 Test Method for Density of Plastics by the Density-
level of confidence concerning the performance of virgin
Gradient Technique
PEEK resins for use in medical devices. The properties listed
D 1898 Practice for Sampling of Plastics
should be considered in selecting material in accordance with
D 3417 Test Method for Enthalpies of Fusion and Crystal-
the specific end-use requirements.
lization of Polymers by Differential Scanning Calorimetry
1.5 When evaluating material in accordance with this speci-
(DSC)
fication, hazardous materials, operations, and equipment may
D 3418 Test Method for Transition Temperatures of Poly-
be involved. This standard does not purport to address all of
mers by Thermal Analysis
the safety concerns, if any, associated with its use. It is the
D 4000 Classification System for Specifying Plastic Mate-
responsibility of the user of this standard to establish appro-
rials
priate safety and health practices and determine the applica-
F 748 Practice for Selecting Generic Biological Test Meth-
bility of regulatory limitations prior to use.
ods for Materials and Devices
2. Referenced Documents 2.2 ISO Standards:
ISO 1628/1 Plastics—Guidelines for the Standardization of
2.1 ASTM Standards:
Methods for Determination of Viscosity Number and
D 149 Test Method for Dielectric Breakdown Voltage and
Dielectric Strength of Solid Electrical Insulating Materials
Annual Book of ASTM Standards, Vol 10.01.
Annual Book of ASTM Standards, Vol 08.01.
1 4
This specification is under the jurisdiction of ASTM Committee F-4 on Medical Discontinued; see 1993 Annual Book of ASTM Standards, Vol 08.01.
and Surgical Materials and Devices and is the direct responsibility of Subcommittee Discontinued; see 1997 Annual Book of ASTM Standards, Vol 08.02.
F04.11 on Polymeric Materials. Annual Book of ASTM Standards, Vol 08.02.
Current edition approved May 10, 2000. Published August 2000. Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 2026
TABLE 2 Typical Properties of Fabricated Forms
Limiting Viscosity Number of Polymers in Dilute
Solution—Part 1: General Conditions Parameter Method Requirement
ISO 1133 Plastics—Determination of the Melt Mass-Flow
Density, kg/m ISO D 1505 1280 - 1320
Tensile Strength, min, MPA, Test Method D 638, 90
Rate (MFR) and the Melt Volume-Flow Rate (MVR) of
Yield Break Type IV, 5.08 cm/min 70
Thermoplastics
Percent elongation, min, % Test Method D 638, Type IV, 40
ISO 10993 Biological Evaluation of Medical Devices, Parts
5.08 cm/min
Izod Impact Strength, min, Test Method D 256, 1.1
1-12
ft-lbf/in. 0.254-cm depth, 0.025-cm
2.3 Other Document:
radius
United States Pharmacopeia, Vol. XXI, or latest edition
Deformation Under Load, Test Methods D 621 (A), 7 2
max,% MPa for 24 h, 23°C, after
Food and Drug Administration, Regulation 21 CFR
90-min recovery
177.1580
3. Terminology 11
5.2 The infrared spectrum of these materials is character-
3.1 Definitions of Terms Specific to This Standard: istic of their molecular repeating units. A representative spec-
3.1.1 fabricated forms—those items into which the virgin trum is listed in Appendix X3. The PEEK resin shall yield an
forms may be converted. These include shapes and forms infrared transmittance spectrum which exhibits major bands
produced by means of machining, extruding, and compression only at the wavelengths listed for a standard reference spec-
molding virgin forms into a subsequent entity (for example, trum of that material.
rods, slabs, sheets, film, or complex shaped parts and devices). 5.2.1 The infrared spectrum, as used in this specification, is
3.1.2 formulated compound—the PEEK materials, parts, or
to identify the specific type of poly aryl ether ketone (PAEK)
devices fabricated from virgin forms in such a way as to present and does not necessarily indicate an acceptable degree
contain intentional or unintentional adjuvant substances.
of material purity.
3.1.3 virgin forms—that form of the PEEK resin as obtained 5.2.2 The presence of additional bands in the sample’s
by the synthesizer. It typically will be in the form of pellets,
infrared spectrum compared to that of the reference material
chips, or blocks. It is the material from which rods, slabs, may indicate a different PAEK or impurities, or both.
sheets, films, or specific parts and devices are fabricated.
5.3 The physical and chemical property requirements for the
virgin resin are listed in Table 1. If additional characteristics
4. Classification
are necessary because of a specific application, the procedures
...
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