[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.
November 2007 ASTM Meeting Updates
At the working group meeting in Tampa, it was announced that the DRAFT PEEK standard F-2026 successfully traversed Main committee ballot and will be published in its current form. It was propose to further update F-2026 to update the biocompatibility statement in the PEEK document. The proposed new language for the biocompatibility statement in F-2026 was based on the UHMWPE standard F648, which demonstrates successful, long-term clinical performance. A recent review article was cited as the basis for the biocompatibility statement in the proposed draft F-2026. There was consensus that the proposed draft be balloted immediately following the meeting. A major update to F-2026 has been recommended to follow the editorial changes in the biocompatibility statement. A revision of the standard was proposed to include detailed test methods to characterize the crystallinity of PEEK; test methods to assess trace contaminants and extractables from PEEK.
Updates Proposed for F-2026 and F-1579 at ASTM
The working group for polyaryletherketones (PAEK) of implants in Subcommittee F04.11 at ASTM proposed revisions to F-2026 that would eliminate references to F-1579 in order to make F-2026 a stand-alone standard for PEEK. The working group agreed that F-1579 as a generic “umbrella document” will eventually be obsolete or modified to exclude PEEK. Additional efforts to update the mechanical properties of PAEKs are concurrently underway and may lead to further revisions of F-2026 for PEEK in the future. The next meeting of the PEEK working group will be on Wednesday, November 14, 2007 at the Tampa Marriott Waterside; Tampa, FL US. Additional meeting details can be found on the ASTM website
ASTM F2026: Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.
The ASTM standard for PEEK, updated in 2007, is consistent with, but more extensive than, F1579. F2026 lists over a dozen standardized test methods that may be used to characterize neat unfilled PEEK materials. In addition to providing requirements for virgin resin, the standard also offers typical minimum physical and mechanical property test values for PEEK biomaterials. Click here to order ASTM Standards online.
ASTM F1579: Standard Specification for Polyarlyetherketone (PAEK) Polymers for Surgical Implant Applications.
This general standard was last published in 2002 and contains only basic terminology and typical mechanical properties for the family of PAEK materials.