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ASTM F 2026 : 2017 : REDLINE

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Available format(s)

PDF

Superseded date

18-08-2023

Language(s)

English

Published date

13-12-2017

CONTAINED IN VOL. 13.01, 2017 Specifies polyetheretherketone (PEEK) polymer in virgin forms as supplied by a vendor (pellets, powder, fabricated forms, and so forth).

1.1This 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.

1.2The 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.

1.3This 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.

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

1.5When 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.

1.6This 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.

Committee
F 04
DocumentType
Redline
Pages
5
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM D 3418 : 2015 : REDLINE Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ASTM D 792 : 2013 : REDLINE Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
ISO 1183:1987 Plastics Methods for determining the density and relative density of non-cellular plastics
ISO 180:2000 Plastics Determination of Izod impact strength
ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM D 648 : 2016 Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
ASTM D 695 : 2015 : REDLINE Standard Test Method for Compressive Properties of Rigid Plastics
ISO 178:2010 Plastics Determination of flexural properties
ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
ISO 527-1:2012 Plastics Determination of tensile properties Part 1: General principles
ASTM D 4000 : 2016 : REDLINE Standard Classification System for Specifying Plastic Materials

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