ASTM F2820-12

Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications

ABSTRACT
This specification covers virgin polyetherketoneketone (PEKK) polymer resin as supplied by a vendor (for example, in pellets, powder, and fabricated forms). 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. As with any material, some characteristics may be altered by the processing techniques (for example, molding, extrusion, machining, assembly, and sterilization) 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. This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEKK polymers for use in medical implant devices. It lists the properties that should be considered in selecting material(s) in accordance with the specific end-use requirements. This specification also addresses classification, properties, sampling, and biocompatibility.
SCOPE
1.1 This specification covers virgin polyetherketoneketone (PEKK) polymer resin as supplied by a vendor (for example, in pellets, powder, and fabricated forms). 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 (for example, molding, extrusion, machining, assembly, and sterilization) 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. With reduced crystallinity, certain polymers have been shown to be more susceptible to environmental stress cracking. Depending upon the implant application, the end user should characterize the material for environmental stress cracking resistance.  
1.3 The properties included in this specification are those applicable for PEKK polymers only. Indicated properties are for fabricated forms. Fabricated forms and materials containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEKK, 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 PEKK polymers for use in medical implant devices. The properties listed should be considered in selecting material(s) in accordance with the specific end-use requirements.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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.

General Information

• Status: Historical
• Publication Date: 14-Apr-2012
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

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
Designation:F2820 −12
Standard Specification for
Polyetherketoneketone (PEKK) Polymers for Surgical
1
Implant Applications
This standard is issued under the fixed designation F2820; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.6 When evaluating material in accordance with this
specification, hazardous materials, operations, and equipment
1.1 This specification covers virgin polyetherketoneketone
maybeinvolved. This standard does not purport to address all
(PEKK)polymerresinassuppliedbyavendor(forexample,in
of the safety concerns, if any, associated with its use. It is the
pellets, powder, and fabricated forms). It provides require-
responsibility of the user of this standard to establish appro-
ments and associated test methods for these thermoplastics
priate safety and health practices and determine the applica-
when they are to be used in the manufacture of intracorporeal
bility of regulatory limitations prior to use.
devices such as surgical implants or components of surgical or
dental devices.
2. Referenced Documents
1.2 As with any material, some characteristics may be
2
2.1 ASTM Standards:
altered by the processing techniques (for example, molding,
D149Test Method for Dielectric Breakdown Voltage and
extrusion, machining, assembly, and sterilization) required for
DielectricStrengthofSolidElectricalInsulatingMaterials
the production of a specific part or device. Therefore, proper-
at Commercial Power Frequencies
ties of fabricated forms of these polymers should be evaluated
D256Test Methods for Determining the Izod Pendulum
using test methods which are appropriate to ensure safety and
Impact Resistance of Plastics
efficacy as agreed upon by the vendor, purchaser, and regulat-
D570Test Method for Water Absorption of Plastics
ing bodies. With reduced crystallinity, certain polymers have
D638Test Method for Tensile Properties of Plastics
been shown to be more susceptible to environmental stress
D648Test Method for Deflection Temperature of Plastics
cracking.Dependingupontheimplantapplication,theenduser
Under Flexural Load in the Edgewise Position
shouldcharacterizethematerialforenvironmentalstresscrack-
D695Test Method for Compressive Properties of Rigid
ing resistance.
Plastics
1.3 The properties included in this specification are those
D696TestMethodforCoefficientofLinearThermalExpan-
applicable for PEKK polymers only. Indicated properties are
sion of Plastics Between −30°C and 30°C with aVitreous
forfabricatedforms.Fabricatedformsandmaterialscontaining
Silica Dilatometer
colorants, fillers, processing aids, or other additives, as well as
D790Test Methods for Flexural Properties of Unreinforced
polymer blends which contain PEKK, or reclaimed materials
and Reinforced Plastics and Electrical Insulating Materi-
are not covered by this specification.
als
D792Test 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
D955Test Method of Measuring Shrinkage from Mold
level of confidence concerning the performance of virgin
Dimensions of Thermoplastics
PEKK polymers for use in medical implant devices. The
D1238Test Method for Melt Flow Rates of Thermoplastics
properties listed should be considered in selecting material(s)
by Extrusion Plastometer
in accordance with the specific end-use requirements.
D1505Test Method for Density of Plastics by the Density-
1.5 The values stated in SI units are to be regarded as
Gradient Technique
standard. No other units of measurement are included in this
3
D1898Practice for Sampling of Plastics (Withdrawn 1998)
standard.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This specification is under the jurisdiction of ASTM Committee F04 on contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Medical and Surgical Materials and Devices and is the direct responsibility of Standards volume information, refer to the standard’s Document Summary page on
Subcommittee F04.11 on Polymeric Materials. the ASTM website.
3
Current edition approved April 15, 2012. Published May 2012. DOI: 10.1520/ The last approved version of this historical standard is referenced on
F2820–12. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2820−12
D3417Test Method for Enthalpies of Fusion and Crystalli- is the material from which fibers, tubes, rods, slabs, sh
...