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ASTM F 1579 Document Information:
Title
Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications
ASTM International
Publication Date:
Apr 10, 2002
Scope:
This specification covers polyaryletherketone (PAEK) polymers in
virgin forms as supplied by a
vendor (pellets, powder, and so forth). It provides requirements and
associated test methods for
these thermoplastics when they are to be used in the manufacture of
intracorporeal devices such as
surgical implants or components of surgical or dental devices.
As with any material, some characteristics may be altered by the
processing techniques (molding,
extrusion, machining, assembly, sterilization, and so forth) required
for the production of a
specific part or device. Therefore, properties of fabricated forms of
these polymers should be
evaluated using test methods that are appropriate to ensure safety and
efficacy as agreed upon by
the vendor, purchaser, and regulating bodies.
The properties included in this specification are those applicable for
PAEK polymers only.
Fabricated forms, material or forms containing colorants, fillers,
processing aids, or other
additives, as well as polymer blends that contain PAEK, are not
covered by this specification.
This specification is designed to recommend physical, chemical, and
biological test methods to
establish a reasonable level of confidence concerning the performance
of unfilled PAEK polymers for
use in medical devices. The properties listed should be considered in
selecting material according
to the specific end-use requirements.
When evaluating material to this specification hazardous materials,
operations, and equipment may
be involved. 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.
Keywords:
- PAEK
- PEEK
- PEEKK
- PEKEKK
- PEKK
- PEK
- polyaryletherketone
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