ASTM F 2759 : 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
02-01-2020
English
04-15-2011
This guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments of ultra-high molecular weight polyethylene (UHMWPE) in implantable orthopedic and spinal devices intended to replace a musculoskeletal joint.
1.1 This guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments of ultra-high molecular weight polyethylene (UHMWPE) in implantable orthopedic and spinal devices intended to replace a musculoskeletal joint. The UHMWPE components may include knee, hip, shoulder, elbow, ankle, total disc replacement, toe, finger, and wrist joint implant devices. This guide does not cover UHMWPE in fiber or tape forms.
1.2 This guide includes a description and rationale of assessments for the various UHMWPE types and processing conditions. Assessment testing based on physical, chemical, biocompatibility, mechanical, and preclinical analyses are briefly described and referenced. The user should refer to specific test methods for additional details.
1.3 This guide does not attempt to define all of the assessment methods associated with UHMWPE components in orthopedic and spinal 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 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 |
Guide
|
| Pages |
6
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| ASTM F 2887 : 2017 | Standard Specification for Total Elbow Prostheses |
| ASTM F 2565 : 2013 | Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
| ASTM F 2381 : 2010 | Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy |
| ASTM D 2765 : 2011 | Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics |
| ASTM F 2025 : 2000 | Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment |
| ASTM D 4020 : 2001 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials |
| ASTM F 2025 : 2006 : R2012 | Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment |
| ASTM F 2003 : 2002 | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| ASTM F 1714 : 1996 : R2008 | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices |
| ASTM F 2102 : 2001 : EDT 1 | Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants |
| ASTM F 2381 : 2019 | Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy |
| ASTM D 2765 : 2001 : R2006 | Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics |
| ASTM F 2625 : 2007 | Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry |
| ASTM F 2423 : 2005 | Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
| ASTM F 2003 : 2002 : R2015 | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| ASTM F 1715 : 2000 | Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices |
| ASTM D 4020 : 2018 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials |
| ASTM D 4020 : 2011 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials |
| ASTM F 2003 : 2002 : R2008 | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| ASTM F 2214 : 2002 | Standard Test Method for<i>In Situ</i> Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
| ASTM F 2102 : 2006 : EDT 1 | Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants |
| ASTM D 2765 : 2001 | Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics |
| ASTM F 2695 : 2007 | Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
| ASTM F 2625 : 2010 | Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry |
| ASTM F 2423 : 2011 | Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
| ASTM F 2025 : 2006 : R2018 | Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment |
| ASTM F 1714 : 1996 : R2002 | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices |
| ASTM D 4020 : 2001 : REV A | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials |
| ASTM F 1714 : 1996 : R2013 | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices |
| ASTM F 2695 : 2012 | Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
| ASTM F 2025 : 2006 | Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment |
| ASTM F 2102 : 2017 | Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants |
| ASTM D 4020 : 2005 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials |
| ASTM F 2423 : 2011 : R2016 | Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
| ASTM F 2183 : 2002 : R2008 | Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017) |
| ASTM F 1714 : 1996 : R2018 | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices |
| ASTM F 1714 : 1996 | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices |
| ASTM F 2381 : 2004 | Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy |
| ASTM F 2183 : 2002 | Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants |
| ASTM D 2765 : 2016 | Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics |
| ASTM F 2214 : 2002 : R2008 | Standard Test Method for <span class="bdit">In Situ</span> Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
| ASTM D 2765 : 1995 | Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics |
| ASTM F 2102 : 2013 | Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants |
| ASTM D 4020 : 2000 : REV A | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials |
| ASTM F 2214 : 2016 | Standard Test Method for <emph type="bdit">In Situ</emph> Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
| ASTM F 2102 : 2001 | Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants |
| ASTM F 2003 : 2000 | Standard Guide for Accelerated Aging of Ultra-High Molecular Weight Polyethylene |
| ASTM F 2625 : 2010 : R2016 | Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry |
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