ASTM F1579-98
(Specification)Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications
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.
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Designation: F 1579 – 98
Standard Specification for
Polyaryletherketone (PAEK) Resins for Surgical Implant
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.
1. Scope D 256 Test Methods for Impact Resistance of Plastics and
Electrical Insulating Materials
1.1 This specification covers polyaryletherketone (PAEK)
D 570 Test Method for Water Absorption of Plastics
resins in virgin forms as supplied by a vendor (flakes, pellets,
D 621 Test Methods for Deformation of Plastics Under
blocks, etc.). It provides requirements and associated test
Load
methods for these thermoplastics when they are to be used in
D 638 Test Method for Tensile Properties of Plastics
the manufacture of intracorporeal devices such as surgical
D 648 Test Method for Deflection Temperature of Plastics
implants or components of surgical or dental devices.
Under Flexural Load
1.2 As with any material, some characteristics may be
D 695 Test Method for Compressive Properties of Rigid
altered by the processing techniques (molding, extrusion,
Plastics
machining, assembly, sterilization, etc.) required for the pro-
D 696 Test Method for Coefficient of Linear Thermal Ex-
duction of a specific part or device. Therefore, properties of
pansion of Plastics
fabricated forms of these resins should be evaluated using test
D 790 Test Methods for Flexural Properties of Unreinforced
methods that are appropriate to ensure safety and efficacy as
and Reinforced Plastics and Electrical Insulating Materi-
agreed upon by the vendor, purchaser, and regulating bodies.
als
1.3 The properties included in this specification are those
D 792 Test Methods for Specific Gravity (Relative Density)
applicable for PAEK resins only. Fabricated forms, material or
and 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 that contain PAEK, are not
Dimensions of Molded Plastics
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 unfilled
Gradient Technique
PAEK resins for use in medical devices. The properties listed
D 1898 Practice for Sampling of Plastics
should be considered in selecting material according to the
D 3417 Test Method for Heats of Fusion and Crystallization
specific end-use requirements.
of Polymers by Thermal Analysis
1.5 When evaluating material to this specification hazardous
D 3418 Test Methods for Transition Temperatures of Poly-
materials, operations, and equipment may be involved. This
mers by Thermal Analysis
standard does not purport to address all of the safety concerns,
D 4000 Classification System for Specifying Plastic Mate-
if any, associated with its use. It is the responsibility of the user
rials
of this standard to establish appropriate safety and health
F 748 Practice for Selecting Generic Biological Test Meth-
practices and determine the applicability of regulatory limita-
ods for Materials and Devices
tions prior to use.
2.2 ISO Documents:
2. Referenced Documents
ISO 1133 Plastics—Determination of the Melt Mass-Flow
Rate (MFR) and the Melt Volume-Flow Rate (MVR) of
2.1 ASTM Standards:
Thermoplastics
D 149 Test Methods for Dielectric Breakdown Voltage and
ISO 1628/1 Plastics, Guidelines for the Standardization of
Dielectric Strength of Solid Electrical Insulating Materials
Methods for Determination of Viscosity Number and
at Commercial Power Frequencies
Limiting Viscosity Number of Polymers in Dilute
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
and Surgical Devices and is under the direct responsibility of Subcommittee F04.11 Annual Book of ASTM Standards, Vol 08.02.
on Polymeric Materials. Annual Book of ASTM Standards, Vol 08.03.
Current edition approved April 10, 1998. Published September 1998. Originally Annual Book of ASTM Standards, Vol 13.01.
published as F 1579 – 95. Last previous edition F 1579 – 95. Available from American National Standards Institute, 11 W. 42nd St., 13th
Annual Book of ASTM Standards, Vol 08.01. Floor, New York, NY 10036.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 1579
TABLE 1 Required Properties of Some PAEK Virgin Resins
T T Melt Flow,
B m
PAEK Type Voscosity Number, (ml/g) Heavy Netaksm (%)
(°C) (°C) (cm /10 min)
ISO 1628, Sulfuric Acid U.S. Pharmacopeia Test
ASTM D 3418, 20°C/min ASTM D 3418, 20°C/min ISO 1133, 400°C, 10 kg
0.5 %, 25°C 231
PEKEKK 160–200 360–400 $55 25–120 #0.1
PEEK 125–165 320–360 $77 #0.1
PEKK 135–175 310–350 40–100 #0.1
PEEKK 140–195 350–390 #0.1
PEK 140–180 350–395 #0.1
TABLE 2 Typical Mechanical Properties of Some PAEK Consolidated Forms
Density, (kg/m ) Tensile Strength, (MPA) Percent Elongation, (%) Izod Impact Strength, Deformation Under Load, (%)
PAEK Type
(Minimum) (Minimum) (Minimum) (ft-lf/in) (Minimum) (Maximum)
ASTM D 256, ASTM D 621 (A),
ASTM D 638, ASTM D 638,
ASTM D 1505 d 5 0.254 cm, 7 MPA, 24 hr, 23°C,
Type IV, 5.08 cm/min Type IV, 5.08 cm/min
r 5 0.025 cm 90 min Rec.
PEKEKK 1.2 90 70 10 0.7 2
PEEK 1.3 90 70 10 1.0 2
PEKK 1.3 10 2
PEEKK 1.3 90 10 2
PEK 10 2
6 8
Solution—Part 1: General Conditions CFR 177.1580 that covers both wet and dry food contact
ISO 10993 Biological Evaluation of Medical Devices, Parts applications.
1–12
6. Chemical Properties
2.3 Other Documents:
United States Pharmacopeia, Vol. XXI, or latest edition
6.1 The required physical and chemical properties of some
virgin PAEK resins are listed in Table 1.
3. Terminology
6.2 The infrared spectrum of these materials is character-
3.1 Definitions of Terms Specific to This Standard:
istic of their molecular repeating units. Representative spectra
3.1.1 fabricated forms—those items into which the virgin
are listed in Appendix X3. The PAEK 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 the standard reference
molding virgin forms into a subsequent entity (for example,
spectrum for the material.
rods, slabs, sheets, film, complex shaped parts and devices).
6.2.1 The infrared spectrum, as used herein, is to identify
3.1.2 formulated compound—PAEK materials, parts, or de-
the specific type of PAEK present and does not necessarily
vices fabricated from virgin forms in such a way as to contain
indicate an acceptable degree of material purity.
intentional or unintentional adjuvant substances.
6.2.2 The presence of additional bands in the sample’s
3.1.3 virgin forms—that form o
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