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ASTM F2695-07

(Specification)

Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications

Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications

ABSTRACT
This specification covers ultra-high molecular weight polyethylene (UHMWPE) powder blended with alphatocopherol (vitamin E) intended for use in surgical implants. The requirements apply to alphatocopherol-containing UHMWPE in two forms. One is virgin polymer powder blended with alpha-tocopherol prior to consolidation. The second is any form fabricated from this blended, alpha-tocopherol-containing powder from which a finished product is subsequently produced. This specification does not apply to finished or semi-finished products that are doped with vitamin E after consolidation, nor to the packaged and sterilized finished implant, nor to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation. Required material characteristics including composition, foreign matter, morphology, and mechanical characteristics are addressed by this specification.
SCOPE
1.1 This specification covers ultra-high molecular weight polyethylene (UHMWPE) powder blended with alpha-tocopherol (vitamin E) intended for use in surgical implants.
1.2 The requirements of this specification apply to alpha-tocopherol-containing UHMWPE in two forms. One is virgin polymer powder blended with alpha-tocopherol prior to consolidation (Section 4). The second is any form fabricated from this blended, alpha-tocopherol-containing powder from which a finished product is subsequently produced (Section 5). This specification does not apply to finished or semi-finished products that are doped with vitamin E after consolidation.
1.3 Aside from blending with alpha-tocopherol, the provisions of Specifications F 648 and D 4020 apply. Special requirements detailed in this specification are added to describe powders containing alpha-tocopherol that will be used in surgical implants. This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant. This specification also does not apply to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.
1.4 The following precautionary caveat pertains only to the fabricated forms portion, Section 5, 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.

General Information

Status
Historical
Publication Date
30-Nov-2007
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.11 - Polymeric Materials
Current Stage
Ref Project

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ASTM F2695-07 - Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant ApplicationsASTM F2695-07 - Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
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ASTM F2695-07 - Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2695 – 07
Standard Specification for
Ultra-High Molecular Weight Polyethylene Powder Blended
With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for
1
Surgical Implant Applications
This standard is issued under the fixed designation F2695; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope D790 Test Methods for Flexural Properties of Unreinforced
and Reinforced Plastics and Electrical Insulating Materials
1.1 This specification covers ultra-high molecular weight
3
D1898 Practice for Sampling of Plastics
polyethylene (UHMWPE) powder blended with alpha-
D4020 Specification for Ultra-High-Molecular-Weight
tocopherol (vitamin E) intended for use in surgical implants.
Polyethylene Molding and Extrusion Materials
1.2 The requirements of this specification apply to alpha-
F619 Practice for Extraction of Medical Plastics
tocopherol-containing UHMWPE in two forms. One is virgin
F648 Specification for Ultra-High-Molecular-Weight Poly-
polymer powder blended with alpha-tocopherol prior to con-
ethylene Powder and Fabricated Form for Surgical Im-
solidation (Section 4). The second is any form fabricated from
plants
this blended, alpha-tocopherol-containing powder from which
F748 Practice for Selecting Generic Biological Test Meth-
a finished product is subsequently produced (Section 5). This
ods for Materials and Devices
specification does not apply to finished or semi-finished
F749 Practice for Evaluating Material Extracts by Intracu-
products that are doped with vitamin E after consolidation.
taneous Injection in the Rabbit
1.3 Aside from blending with alpha-tocopherol, the provi-
F756 Practice for Assessment of Hemolytic Properties of
sions of Specifications F648 and D4020 apply. Special require-
Materials
ments detailed in this specification are added to describe
F763 Practice for Short-Term Screening of Implant Materi-
powders containing alpha-tocopherol that will be used in
als
surgical implants. This specification addresses material char-
F813 Practice for Direct Contact Cell Culture Evaluation of
acteristics and does not apply to the packaged and sterilized
Materials for Medical Devices
finished implant. This specification also does not apply to
F895 Test Method for Agar Diffusion Cell Culture Screen-
UHMWPE materials extensively crosslinked by gamma and
ing for Cytotoxicity
electron beam sources of ionizing radiation.
F981 Practice forAssessment of Compatibility of Biomate-
1.4 The following precautionary caveat pertains only to the
rials for Surgical Implants with Respect to Effect of
fabricated forms portion, Section 5, of this specification. This
Materials on Muscle and Bone
standard does not purport to address all of the safety concerns,
2.2 ISO Standards:
if any, associated with its use. It is the responsibility of the user
ISO 3451-1 Plastics—Determination of Ash, Part 1: Gen-
of this standard to establish appropriate safety and health
4
eral Methods
practices and determine the applicability of regulatory limita-
ISO 10993 Biological Evaluation of Medical Devices, Parts
tions prior to use.
4
1–12
2. Referenced Documents
3. Terminology
2
2.1 ASTM Standards:
3.1 Definitions of Terms Specific to This Standard:
D648 Test Method for Deflection Temperature of Plastics
3.1.1 crosslinking—the process by which ionizing irradia-
Under Flexural Load in the Edgewise Position
tion produces chemical bonds between two UHMWPE mol-
ecules.
1
3.1.2 extensively crosslinked UHMWPE—UHMWPE mate-
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
rial that has been subjected to total doses of gamma and/or
Subcommittee F04.11 on Polymeric Materials.
electron beam ionizing irradiation greater than 40 kGy.
Current edition approved Dec. 1, 2007. Published December 2007. DOI:
10.1520/F2695-07.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
3
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Withdrawn.
4
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2695 – 07
3.1.3 fabricated form—any bulk shape of UHMWPE, fab- 5.1.2 Uniformity of the alpha-tocopherol in the fabricated
ricated from the virgin polymer powder, used during th
...

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A1.1 Significance and Use
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1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
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 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Technical specification
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  • Technical specification
    22 pages
    English language
    sale 15% off