[Standards]
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.
May 2010 PEEK Standard Update
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.
New ASTM Crystallinity Index Standard Published
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.
New ASTM Crystallinity Index Standard Method in Development for Medical Grade PEEK
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.
New Medical Grade PEEK Standard Published by ASTM
At the November 2008 ASTM meeting in St. Louis, it was announced that the standard for medical grade PEEK has been published. The updated standard is entitled "ASTM F2026 - 08, Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications." The standard is now available for download from the astm website (www.astm.org).
A new draft standard method for measurement of crystallinity in medical grade PEEK using R-FTIR was also introduced at the November 2008 ASTM meeting and will be circulated for ballot in December.
May 2008 ASTM Meeting Update
The working group convened in Denver and discussed ballot results for the updated medical grade PEEK standard, F-2026-07a. This standard is undergoing revision to the biocompatibility statement in the PEEK document. Work is also underway to develop more detailed test methods to characterize the crystallinity of PEEK.