ASTM F648-07
(Specification)Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
SCOPE
1.1 This specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.
1.2 The 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.
1.3 The provisions of Specification D 4020 apply. Special requirements detailed in this specification are added to describe material which will be used in surgical implants.
1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1, 2, 3) and by laboratory studies (4,5 6, ).
The 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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Designation: F 648 – 07
Standard Specification for
Ultra-High-Molecular-Weight Polyethylene Powder and
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Fabricated Form for Surgical Implants
This standard is issued under the fixed designation F 648; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope and Reinforced Plastics and Electrical Insulating Materials
D 792 TestMethodsforDensityandSpecificGravity(Rela-
1.1 This specification covers ultra-high molecular weight
tive Density) of Plastics by Displacement
polyethylene powder (UHMWPE) and fabricated forms in-
D 1505 Test Method for Density of Plastics by the Density-
tended for use in surgical implants.
Gradient Technique
1.2 The requirements of this specification apply to UHM-
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D 1898 Practice for Sampling of Plastics
WPE in two forms. One is virgin polymer powder (Section 4).
D 4020 Specification for Ultra-High-Molecular-Weight
The second is any form fabricated from this powder from
Polyethylene Molding and Extrusion Materials
which a finished product is subsequently produced (Section 5).
F 619 Practice for Extraction of Medical Plastics
This specification addresses material characteristics and does
F 748 Practice for Selecting Generic Biological Test Meth-
not apply to the packaged and sterilized finished implant.
ods for Materials and Devices
1.3 The provisions of Specification D 4020 apply. Special
F 749 Practice for Evaluating Material Extracts by Intracu-
requirementsdetailedinthisspecificationareaddedtodescribe
taneous Injection in the Rabbit
material which will be used in surgical implants.
F 756 Practice for Assessment of Hemolytic Properties of
1.4 The biological response to polyethylene in soft tissue
Materials
and bone has been well characterized by a history of clinical
2
F 763 Practice for Short-Term Screening of Implant Mate-
use (1, 2, 3) and by laboratory studies (4, 5, 6).
rials
1.5 The following precautionary caveat pertains only to the
F 813 PracticeforDirectContactCellCultureEvaluationof
test method portion, Section 7, of this specification: This
Materials for Medical Devices
standard does not purport to address all of the safety concerns,
F 895 Test Method forAgar Diffusion Cell Culture Screen-
if any, associated with its use. It is the responsibility of the user
ing for Cytotoxicity
of this standard to establish appropriate safety and health
F 981 Practice for Assessment of Compatibility of Bioma-
practices and determine the applicability of regulatory limita-
terials for Surgical Implants with Respect to Effect of
tions prior to use.
Materials on Muscle and Bone
2. Referenced Documents 2.2 ISO Standards
5
3
ISO 527 Plastics: Determination of Tensile Properties
2.1 ASTM Standards:
ISO 3451-1 Plastics—Determination of Ash, Part 1: Gen-
D 256 Test Methods for Determining the Izod Pendulum
5
eral Methods
Impact Resistance of Plastics
ISO 11542/2, Plastics—Ultra-High Molecular Weight Poly-
D 638 Test Method for Tensile Properties of Plastics
ethylene (UHMWPE) Moulding and Extrusion
D 648 Test Method for Deflection Temperature of Plastics
Materials—Part 2: Preparation of Test Specimens and
Under Flexural Load in the Edgewise Position
5
Determination
D 790 TestMethodsforFlexuralPropertiesofUnreinforced
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
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This specification is under the jurisdiction of ASTM Committee F04 on
3.1.1 fabricated form, n—any bulk shape of UHMWPE,
Medical and Surgical Materials and Devices and is the direct responsibility of
fabricated from the virgin polymer powder and used during the
Subcommittee F04.11 on Polymeric Materials.
process of fabricating surgical implants prior to packaging and
Current edition approved Feb. 1, 2007. Published February 2007. Originally
approved in 1996. Last previous edition approved in 2004 as F 648 – 04.
sterilization.
2
The boldface numbers in parentheses refer to the list of references at the end of
this specification.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Withdrawn.
5
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.
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F648–07
3.1.1.1 Discussion—This form results from the application 5.2 Physical Requirements:
of heat and pressure to the virgin polymer pow
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