This webpage identifies the current standards for medical grade PAEKs at the American Society for Testing and Materials (ASTM). There are currently no standards for medical grade PEEK at the International Organization for Standardization (ISO). A detailed discussion about the standards for medical grade PAEKs can be found in Chapter 3 of the Medical PEEK Lexicon.
At the May 2012 ASTM meeting in Phoenix, the results of ballots for the PEEK standard specification F2026 was reviewed. The material standards has been updated to include quality system requirements for the production of resin and stock shapes. The task force also reviewed the results of a draft ISO protocol for measuring the transition temperatures of PEEK using DSC. The PEKK standard specification, which was updated to include quality system requirements, has passed Main ballot and been cleared for publication. The next task force meeting will be in November 2012 in Atlanta Georgia. Please also see the F04 meeting webpage on the ASTM website for more details about future task force meetings.
At the November 2010 ASTM meeting in San Antonio, it was announced that the updated standard for medical grade PEEK has been published with a revised biocompatibility section. The updated standard is entitled "ASTM F2026 - 10, Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications." The standard is now available for download from the ASTM website.
The PEEK task force at ASTM has been reorganized to include the material specification standards as well as test method standards specific to PEEK biomaterials. The next meeting of the PEEK task force will be at the Wednesday, May 18, 2011, meeting at the Marriott Anaheim; Anaheim, CA US. Please see the F04 meeting webpage on the ASTM website for more details.
At the May 2010 ASTM Meeting in St. Louis, standard development activity continued for ASTM F2026, Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. The current working draft includes an update of the biocompatibility section. The revised standard will be ballotted in July/August 2010, and the results of this activity will be discussed at the November 2010 meeting of F04, between Tuesday November 16th 2010 - Friday November 19th 2010, at the Grand Hyatt San Antonio; San Antonio, TX US.
At the end of 2009, ASTM published the reflectance-FTIR method for evaluating crystallinity in PEEK. The standard is designated as "F2778-09 Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR)." The test method task force for PEEK is now concentrating on expanding the small punch test standard to include PEEK biomaterials.
A new "Standard Test Method for Measurement of the Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR)" is currently under active development under the auspices of ASTM, under the Work Item 22045. This draft standard has been through multiple ballots, and is expected to be finalized shortly. Even after the procedure is approved by ASTM, the next step will be to initiate a round robin to evaluate the interlaboratory precision and bias. The next meeting to discuss this standard and the interlaboratory study will be at the ASTM committee week in November 2009.