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ASTM F 1579 : 2002

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

10-04-2002

CONTAINED IN VOL. 13.01, 2009 Covers polyaryletherketone (PAEK) resins in virgin forms as supplied by a vendor (flakes, pellets, blocks, etc.). Also provides requirements and associated test methods for these thermo plastics when they are to be used in the manufacture of intra-corporal devices such as surgical implants or components of surgical or dental devices.

1.1 This specification covers polyaryletherketone (PAEK) polymers in virgin forms as supplied by a vendor (pellets, powder, 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 As with any material, some characteristics may be altered by the processing techniques (molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of these polymers should be evaluated using test methods that are appropriate to ensure 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 PAEK polymers only. Fabricated forms, material or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends that contain PAEK, 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 unfilled PAEK polymers for use in medical devices. The properties listed should be considered in selecting material according to the specific end-use requirements.

1.5 When evaluating material to 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.

Committee
F 04
DocumentType
Standard
Pages
6
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

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
CFR 21(PTS170-199) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 170-199
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 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
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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