ASTM F2026-23 PDF
Name in English:
St ASTM F2026-23
Name in Russian:
Ст ASTM F2026-23
Original standard ASTM F2026-23 in PDF full version. Additional info + preview on request
Full title and description
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications (Designation: ASTM F2026-23). This specification defines required properties, test methods, and acceptance criteria for virgin PEEK polymers supplied for use in intracorporeal surgical implants and related fabricated components.
Abstract
This specification covers polyetheretherketone (PEEK) polymer in virgin forms (for example: pellets, granules, powder, filaments for additive manufacturing) and fabricated forms intended for manufacture of intracorporeal surgical or dental implants. It specifies recommended physical, chemical and biological test methods (density, tensile, flexural, impact, DSC, USP-type analyses and biocompatibility references) and excludes PEEK-containing blends, filled or reclaimed materials.
General information
- Status: Active / Published
- Publication date: Current edition approved August 1, 2023 (published August 2023; record entries also show 31 July 2023 in some catalog listings).
- Publisher: ASTM International (ASTM F04 Committee, Subcommittee F04.11).
- ICS / categories: 11.040.30 (Surgical instruments and materials).
- Edition / version: F2026-23 (revises F2026-17).
- Number of pages: 5 pages (concise specification document).
Scope
The scope includes virgin PEEK homopolymer (semicrystalline EEK repeat unit) in vendor-supplied forms and fabricated items intended for intracorporeal use. The standard sets property requirements and references test methods to provide confidence in material performance for implant applications, while explicitly excluding colored, filled, additive-containing, blended or reclaimed materials. It also notes that processing and sterilization can alter properties and that fabricated forms should be evaluated with appropriate methods.
Key topics and requirements
- Definition of the PEEK polymer form and chemical structure (homopolymer EEK).
- Required physical property evaluations: density, tensile strength, elongation, flexural strength, flexural modulus, impact strength.
- Chemical and thermal characterization: infrared/USP-type identity/viscosity, total heavy metals (lead) screening, differential scanning calorimetry (DSC) for crystallinity/transition temperatures.
- Referenced test methods: applicable ASTM D-series plastics tests (for example D638, D256, D790, D695, D1505, D3418, D648) and ISO/USP/biocompatibility standards.
- Biocompatibility considerations and reference to ISO 10993 biological evaluation practices.
- Exclusions: compounded, colored, filled, blended or reclaimed materials; requirements apply to virgin PEEK only.
Typical use and users
Used by medical device and implant manufacturers, polymer suppliers, material selection and quality engineers, test laboratories, regulatory and conformity-assessment professionals, and design groups specifying implantable components or additive-manufactured PEEK parts. The standard helps purchasers and manufacturers agree on material acceptance criteria for intracorporeal devices.
Related standards
Commonly referenced documents include: ASTM test methods for plastics (D638, D256, D790, D695, D1505, D3418, D648), ISO 10993 series (biological evaluation of medical devices), ISO 13485 (medical device quality systems), USP tests for polymer identity/viscosity/heavy metals, and other ASTM F‑series standards for implantable materials. F2026-23 replaces/revises F2026-17.
Keywords
PEEK, polyetheretherketone, surgical implant, implantable polymer, biocompatibility, tensile strength, flexural modulus, DSC, virgin polymer, additive manufacturing, ASTM F2026-23.
FAQ
Q: What is this standard?
A: ASTM F2026-23 is the ASTM International specification that defines required properties, test methods and acceptance guidance for virgin PEEK polymers intended for use in intracorporeal surgical and dental implants.
Q: What does it cover?
A: It covers virgin PEEK in vendor-supplied forms (pellets, powder, filaments, fabricated parts) and specifies physical, chemical and biological test methods (density, tensile/flexural/impact properties, DSC, USP-type analyses) to establish confidence in material performance for implant applications. It excludes filled, colored, blended or reclaimed materials.
Q: Who typically uses it?
A: Medical device manufacturers, implant designers, materials suppliers, testing laboratories, regulatory affairs and quality engineers use F2026-23 when selecting, procuring or qualifying PEEK materials for implantable devices.
Q: Is it current or superseded?
A: Current — the F2026-23 edition is the active edition, approved August 1, 2023, and supersedes the prior F2026-17 edition.
Q: Is it part of a series?
A: It is maintained by ASTM Committee F04 (Medical and Surgical Materials and Devices), Subcommittee F04.11 (Polymeric Materials). It is commonly used alongside other ASTM F‑series and ISO standards for implantable materials and device quality systems.
Q: What are the key keywords?
A: PEEK, polyetheretherketone, implantable polymer, surgical implant, biocompatibility, tensile, flexural, DSC, ASTM F2026-23.