ASTM F 648 : 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Hardcopy , PDF
03-05-2021
English
28-04-2014
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
F 04
|
| DocumentType |
Standard
|
| Pages |
8
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
1.1This specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.
1.2The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second is any form fabricated from this powder from which a finished product is subsequently produced (Section 5). This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant.
1.3The requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked or blended with other additives, for example, antioxidants.
1.4The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1, 2, 3)2 and by laboratory studies (4, 5, 6).
1.5The values stated in SI units are to be regarded as standard.
1.6The following precautionary caveat pertains only to the test method portion, Section 7, of this specification: 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.
| ASTM F 2091 : 2015 | Standard Specification for Acetabular Prostheses (Withdrawn 2023) |
| ASTM F 1814 : 2015 | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| ASTM F 2565 : 2013 | Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
| ASTM F 755 : 2019 | Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
| ASTM F 763 : 2004 : R2016 | Standard Practice for Short-Term Screening of Implant Materials |
| ASTM F 1714 : 1996 : R2018 | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices |
| ASTM F 732 : 2017 | Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
| ASTM F 981 : 2004 : R2016 | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone |
| ASTM F 2027 : 2016 | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| ASTM F 2224 : 2009 : R2020 | Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
| ASTM F 1672 : 2014 : R2019 | Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023) |
| ASTM F 2665 : 2021 | Standard Specification for Total Ankle Replacement Prosthesis |
| ASTM F 2695 : 2012 : R2020 | Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
| ASTM F 1408 : 2020 : REV A | Standard Practice for Subcutaneous Screening Test for Implant Materials |
| ASTM F 2887 : 2017 | Standard Specification for Total Elbow Prostheses |
| ASTM F 2083 : 2021 | Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023) |
| ASTM F 2759 : 2019 | Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices |
| ASTM F 2193 : 2020 | Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System |
| ASTM F 1378 : 2018 : EDT 1 | Standard Specification for Shoulder Prostheses |
| ASTM F 2003 : 2002 : R2015 | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| ASTM D 4020 : 2001 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials |
| ASTM D 1505 : 2003 | Standard Test Method for Density of Plastics by the Density-Gradient Technique |
| 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 D 1898 : 1968 : R1989 | Standard Practice for Sampling of Plastics (Withdrawn 1998) |
| ASTM D 4020 : 2001 : REV A | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials |
| ASTM D 1505 : 1968 : R1979 | Standard Test Method for Density Of Plastics By The Density-Gradient Technique |
| ASTM D 4020 : 2005 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials |
| ASTM F 763 : 1999 | Standard Practice for Short-Term Screening of Implant Materials |
| ASTM D 1505 : 2010 | Standard Test Method for Density of Plastics by the Density-Gradient Technique |
| ASTM D 1505 : 2018 | Standard Test Method for Density of Plastics by the Density-Gradient Technique |
| ASTM D 1505 : 1998 : EDT 1 | Standard Test Method for Density of Plastics by the Density-Gradient Technique |
| ASTM D 4020 : 2000 : REV A | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.