ASTM-F2026 2023(Redline)

$40.63

F2026-23 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications (Redline)

Published By	Publication Date	Number of Pages
ASTM	2023

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Categories: 11.040.30 - Surgical instruments and materials, ASTM

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Description

ASTM F2026-23

Redline Standard: Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

ASTM F2026

Scope

1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms (for example, pellets, granules, powder, filaments used in additive manufacturing) 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 The properties included in this specification are those applicable for PEEK polymers only. Indicated properties are for fabricated forms. Materials or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification.

1.3 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEEK polymers for use in medical implant devices.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Keywords

PEEK; polyetheretherketone;

ICS Code

ICS Number Code 11.040.30 (Surgical instruments and materials)

DOI: 10.1520/F2026-23

Additional information

Standard Title	F2026-23 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications (Redline)
Published Code	ASTM
Publication Date	2023
ICS Codes	11.040.30 - Surgical instruments and materials