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ASTM F 1876 : 1998

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications
Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

10-04-1998

CONTAINED IN VOL. 13.01, 2009 Covers polyetherketoneetherketoneketone (PEKEKK) resins in virgin forms as supplied by a vendor, such as flakes, pellets, blocks, etc. Provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacturing of intracorporeal devices, such as surgical implants or components of surgical or dental devices.

1.1 This specification covers polyetherketoneetherketoneketone (PEKEKK) resins in virgin forms as supplied by a vendor, such as flakes, pellets, blocks, etc. It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacturing of intracorporeal devices, such as surgical implants or components of surgical or dental devices.

1.2 As with any material, some characteristics may be altered by the processing techniques, such as molding, extrusion, machining, assembly, sterilization, etc. required for the production of a specific part or device; therefore, properties of fabricated forms of these resins should be evaluated using test methods that are appropriate to assure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies.

1.3 The properties included in this specification are those applicable for PEKEKK resins only. Fabricated forms, material or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends tht contain PEKEKK, are not covered by this specification.

1.4 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEKEKK resins for use in medical devices. The properties listed should be considered in selecting material according to the specific end-use requirement.

1.5 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.

Committee
F 04
DocumentType
Standard
Pages
5
ProductNote
Reconfirmed 1998
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products

ASTM D 3418 : 2015 : REDLINE Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
ISO 1628-1:2009 Plastics Determination of the viscosity of polymers in dilute solution using capillary viscometers Part 1: General principles
ASTM D 1238 : 2013 : REDLINE Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 792 : 2013 : REDLINE Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
ASTM D 696 : 2016 : REDLINE Standard Test Method for Coefficient of Linear Thermal Expansion of Plastics Between −30°C and 30°C with a Vitreous Silica Dilatometer
ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
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
ASTM D 570 : 1998 : R2018 Standard Test Method for Water Absorption of Plastics
ISO 1133:2005 Plastics Determination of the melt mass-flow rate (MFR) and the melt volume-flow rate (MVR) of thermoplastics
ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
ASTM D 4000 : 2016 : REDLINE Standard Classification System for Specifying Plastic Materials

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