ASTM F 755 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
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ASTM F 755 Document Information:
Title
Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
ASTM International
Publication Date:
Aug 10, 1999
Scope:
This specification covers the properties and test methods for porous
high density and ultra high
molecular weight polyethylenes intended for use in surgical implants.
The porous polyethylene may
be used as a free standing product or as a coating on a substrate in
nonloaded applications.
Evaluation of tissue response to a porous polyethylene must be
completed. Guidance in establishing
biocompatibility may be found in the list of references.
Clinical experience and animal studies have shown that tissue will
grow into the open pores of
porous polyethylene. The tissue ingrowth into the pores may allow for
the establishment of implant
fixation.
This section 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.
Keywords:
- plastic surgical devices/applications
- polyethylene (PE) plastics/surgical implant applications
- polymers-surgical applicant
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