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  • ASTM
    F2026-16 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
    Edition: 2016
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    Unlimited Users per year

Description of ASTM-F2026 2016

ASTM F2026-16

Historical 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 as supplied by a vendor (pellets, powder, fabricated forms, and so forth). 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 and health practices and determine the applicability of regulatory limitations prior to use.


Keywords

PEEK; polyetheretherketone;


ICS Code

ICS Number Code 11.040.30 (Surgical instruments and materials)


DOI: 10.1520/F2026-16

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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