ASTM F 648 : 2014 : REDLINE
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
05-03-2021
English
03-01-2014
CONTAINED IN VOL. 13.01, 2015 Specifies Ultra-High Molecular Weight Polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.
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.
| Committee |
F 04
|
| DocumentType |
Redline
|
| Pages |
11
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy |
| ASTM F 763 : 2004 : R2010 | Standard Practice for Short-Term Screening of Implant Materials |
| BS 3531-20:1986 | Surgical implants Specification for ultra-high molecular mass polyethylene in powder form |
| BS ISO 5834-3:2005 | Implants for surgery. Ultra-high-molecular-weight polyethylene Accelerated ageing methods |
| CSA ISO 10993-12 : 98(R2002) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - SAMPLE PREPARATION AND REFERENCE MATERIALS |
| ASTM F 2665 : 2009 | Standard Specification for Total Ankle Replacement Prosthesis |
| ASTM F 1715 : 2000 | Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices |
| ASTM F 1408 : 1997 : R2002 : EDT 1 | Standard Practice for Subcutaneous Screening Test for Implant Materials |
| ASTM F 1357 : 2014 : REDLINE | Standard Specification for Articulating Total Wrist Implants |
| ASTM F 2665 : 2009 : R2014 | Standard Specification for Total Ankle Replacement Prosthesis |
| ASTM F 1714 : 1996 : R2008 | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices |
| NBR 15752-1 : 2015 | IMPLANTS FOR ORTHOPEDICS - SHOULDER PROSTHESIS - PART 1: SPECIFICATIONS |
| NBR 15719 : 2016 | IMPLANTS FOR ORTHOPEDICS - HIP JOINT PROSTHESES - SPECIFICATION FOR ACETABULAR PROSTHESES |
| NBR 15744-3 : 2013 | IMPLANTS FOR SURGERY - TEST METHODS FOR ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE (UHMWPE) CHARACTERIZATION - PART 3: EVALUATING TRANS-VINYLENE YIELD IN IRRADIATED COMPONENTS BY INFRARED SPECTROSCOPY |
| BS ISO 5834-2:2011 | Implants for surgery. Ultra-high-molecular-weight polyethylene Moulded forms |
| ASTM F 2224 : 2009 | Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
| ISO 5834-5:2005 | Implants for surgery Ultra-high-molecular-weight polyethylene Part 5: Morphology assessment method |
| ASTM F 981 : 2004 : R2010 | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone |
| ASTM F 1408 : 1997 : R2013 | Standard Practice for Subcutaneous Screening Test for Implant Materials |
| DIN ISO 5834-2:2014-02 | IMPLANTS FOR SURGERY - ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE - PART 2: MOULDED FORMS (ISO 5834-2:2011) |
| ASTM F 1672 : 2014 : REDLINE | Standard Specification for Resurfacing Patellar Prosthesis |
| ASTM F 981 : 2004 | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone |
| ASTM F 1814 : 2015 : REDLINE | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| ASTM F 755 : 1999 : EDT 1 | Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
| ASTM F 2565 : 2013 : REDLINE | Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
| NF ISO 5834-2 : 2006 | IMPLANTS FOR SURGERY - ULTRA-HIGH MOLECULAR-WEIGHT POLYETHYLENE - PART 2: MOULDED FORMS |
| ASTM F 2224 : 2009 : R2014 | Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
| ASTM F 982 : 1986 : R2002 | Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion |
| ASTM F 732 : 2017 : REDLINE | Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
| ASTM F 2027 : 2016 : REDLINE | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| ASTM F 763 : 2004 | Standard Practice for Short-Term Screening of Implant Materials |
| ASTM F 1714 : 1996 : R2002 | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices |
| ASTM F 2759 : 2011 : REDLINE | Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices |
| ASTM F 2003 : 2002 | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| ASTM F 1408 : 1997 : R2008 | Standard Practice for Subcutaneous Screening Test for Implant Materials |
| 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 2091 : 2015 : REDLINE | Standard Specification for Acetabular Prostheses |
| ASTM F 755:1999 | Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
| 04/30031040 DC : 0 | ISO 5834-3 - IMPLANTS FOR SURGERY - ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE - PART 3: ACCELERATED AGEING METHODS |
| ISO 5834-2:2011 | Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms |
| 04/30099319 DC : DRAFT APR 2004 | ISO 5834-5 - IMPLANTS FOR SURGERY - ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE - PART 5: MORPHOLOGY ASSESSMENT METHOD |
| 17/30360581 DC : 0 | BS ISO 5834-2 - IMPLANTS FOR SURGERY - ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE - PART 2: MOULDED FORMS |
| ASTM F 755 : 1999 : R2005 | Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
| ASTM F 982 : 1986 : R1998 | Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion |
| ASTM F 982 : 1986 : R2008 | Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017) |
| ASTM F 763 : 2004 : R2016 | Standard Practice for Short-Term Screening of Implant Materials |
| ASTM F 1408 : 1997 | Standard Practice for Subcutaneous Screening Test for Implant Materials |
| ASTM F 2695 : 2012 : REDLINE | Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
| ISO 5834-3:2005 | Implants for surgery Ultra-high-molecular-weight polyethylene Part 3: Accelerated ageing methods |
| BS ISO 5834-5:2005 | Implants for surgery. Ultra-high molecular weight polyethylene Morphology assessment method |
| ASTM F 755 : 1999 : R2011 | Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
| ASTM PS 5 : 1994 | Test Method for Static and Dynamic Test Method for Spinal Implants Assembly in a Corpectomy Model (Withdrawn 1997) |
| ASTM F 2003 : 2002 : R2015 | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| 17/30360590 DC : 0 | BS ISO 5834-5 - IMPLANTS FOR SURGERY - ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE - PART 5: MORPHOLOGY ASSESSMENT METHOD |
| ASTM F 1714 : 1996 | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices |
| ASTM F 2887 : 2017 : REDLINE | Standard Specification for Total Elbow Prostheses |
| ASTM F 1714 : 1996 : R2013 | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices |
| ASTM F 2183 : 2002 | Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants |
| ASTM F 2003 : 2002 : R2008 | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| 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 2083 : 2012 : REDLINE | Standard Specification for Knee Replacement Prosthesis |
| ISO 3451-1:2008 | Plastics Determination of ash Part 1: General methods |
| ASTM F 756 : 2017 : REDLINE | Standard Practice for Assessment of Hemolytic Properties of Materials |
| ISO 11542-2:1998 | Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 2: Preparation of test specimens and determination of properties |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ASTM F 749 : 2013 : REDLINE | Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit |
| ASTM D 792 : 2013 : REDLINE | Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
| ASTM F 619 : 2014 : REDLINE | Standard Practice for Extraction of Medical Plastics |
| 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 |
| ISO 9001:2015 | Quality management systems — Requirements |
| ASTM D 648 : 2016 | Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
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