Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
|Publication Date:||15 November 2017|
|ICS Code (Surgical instruments and materials):||11.040.30|
This specification covers polyetheretherketone
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.
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.
The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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.
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.