ASTM F 648 : 2014 : REDLINE
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Available format(s)
PDF
Superseded date
03-05-2021
Superseded by
Language(s)
English
Published date
01-03-2014
Important note : Users cannot be edited or removed once added to your Multi user PDF.CONTAINED IN VOL. 13.01, 2015 Specifies Ultra-High Molecular Weight Polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.
| Committee |
F 04
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| DocumentType |
Redline
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| Pages |
11
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| PublisherName |
American Society for Testing and Materials
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| Status |
Superseded
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| SupersededBy |
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.
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| 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 |
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| 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) |
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| 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 |
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| 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 |
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| 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 |
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| 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) |
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