ASTM F2695-12

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 F648 and D4020 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: 14-May-2012
• 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

Standards Content (Sample)

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 −12
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 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This specification covers ultra-high molecular weight
D648 Test Method for Deflection Temperature of Plastics
polyethylene (UHMWPE) powder blended with alpha-
Under Flexural Load in the Edgewise Position
tocopherol (vitamin E) intended for use in surgical implants.
D790 Test Methods for Flexural Properties of Unreinforced
1.2 The requirements of this specification apply to alpha-
and Reinforced Plastics and Electrical Insulating Materi-
tocopherol-containing UHMWPE in two forms. One is virgin
als
3
polymer powder blended with alpha-tocopherol prior to con- D1898 Practice for Sampling of Plastics (Withdrawn 1998)
solidation (Section 4). The second is any form fabricated from D4020 SpecificationforUltra-High-Molecular-WeightPoly-
ethylene Molding and Extrusion Materials
this blended, alpha-tocopherol-containing powder from which
F619 Practice for Extraction of Medical Plastics
a finished product is subsequently produced (Section 5). This
F648 Specification for Ultra-High-Molecular-Weight Poly-
specification does not apply to finished or semi-finished
ethylene Powder and Fabricated Form for Surgical Im-
products that are doped with vitamin E after consolidation.
plants
1.3 Aside from blending with alpha-tocopherol, the provi-
F748 PracticeforSelectingGenericBiologicalTestMethods
sions of Specifications F648 and D4020 apply. Special require-
for Materials and Devices
ments detailed in this specification are added to describe
F749 Practice for Evaluating Material Extracts by Intracuta-
powders containing alpha-tocopherol that will be used in
neous Injection in the Rabbit
surgical implants. This specification addresses material char-
F756 Practice for Assessment of Hemolytic Properties of
acteristics and does not apply to the packaged and sterilized
Materials
finished implant. This specification also does not apply to F763 Practice for Short-Term Screening of Implant Materi-
UHMWPE materials extensively crosslinked by gamma and als
F813 Practice for Direct Contact Cell Culture Evaluation of
electron beam sources of ionizing radiation.
Materials for Medical Devices
1.4 The following precautionary caveat pertains only to the
F895 TestMethodforAgarDiffusionCellCultureScreening
fabricated forms portion, Section 5, of this specification. This
for Cytotoxicity
standard does not purport to address all of the safety concerns,
F981 Practice for Assessment of Compatibility of Biomate-
if any, associated with its use. It is the responsibility of the user
rials for Surgical Implants with Respect to Effect of
of this standard to establish appropriate safety and health
Materials on Muscle and Bone
practices and determine the applicability of regulatory limita-
2.2 ISO Standards:
tions prior to use.
ISO3451–1 Plastics—DeterminationofAsh,Part1:General
4
Methods
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
1
This specification is under the jurisdiction of ASTM Committee F04 on Standards volume information, refer to the standard’s Document Summary page on
Medical and Surgical Materials and Devices and is the direct responsibility of the ASTM website.
3
Subcommittee F04.11 on Polymeric Materials. The last approved version of this historical standard is referenced on
Current edition approved May 15, 2012. Published June 2012. Originally www.astm.org.
4
approved in 2007. Last previous edition approved in 2007 as F2695 – 07. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2695-12. 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

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F2695−12
ISO 10993 Biological Evaluation of Medical Devices, Parts 4.3.1.2 When measured based on agreement between the
4
1–12 vendor and purchaser, the alpha-tocopherol content added to
the powder shall be reported in units of ppm and percent mass.
3. Terminology 4.3.1.3 Uniformity of the alpha-tocopherol in the blended
powder will be measured based on agreement between the
3.1 Definitions of Terms Specific to This Standard:
vendor and the purch
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F2695–07 Designation: F2695 – 12
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
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 F648 and D4020 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D1898 Practice for Sampling of Plastics
D4020 Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials
F619 Practice for Extraction of Medical Plastics
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F756 Practice for Assessment of Hemolytic Properties of Materials
F763 Practice for Short-Term Screening of Implant Materials
F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
2.2 ISO Standards:
3
ISO 3451-1ISO 3451–1 Plastics—Determination of Ash, Part 1: General Methods
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.11 on Polymeric Materials.
Current edition approved Dec. 1, 2007. Published December 2007. DOI: 10.1520/F2695-07.
Current edition approved May 15, 2012. Published June 2012. Originally approved in 2007. Last previous edition approved in 2007 as F2695 – 07. DOI:
10.1520/F2695-12.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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F2695 – 12
3
ISO 10993 Biological Evaluation of Medical Devices, Parts 1–12
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 crosslinking—the process by which ionizing irradiation produces chemical bonds between two UHMWPE molecules.
3.1.2 extensively crossli
...