ASTM F 1441 Standard Specification for Soft-Tissue Expander Devices
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ASTM F 1441 Document Information:
Title
Standard Specification for Soft-Tissue Expander Devices
ASTM International
Publication Date:
Apr 10, 2003
Scope:
This specification covers the requirements for single use saline
inflatable, smooth and textured
tissue expansion devices to be used intraoperatively or implanted for
typically less than 6 months
and then removed.
Limitations:
This specification applies only to soft-tissue expander devices
fabricated with elastomer shells.
It does not necessarily cover any custom fabricated soft tissue
expander device manufactured to any
other specification.
This specification applies, in part, to combination "expander/mammary"
devices as classified in
Section 4.
The values stated in SI units are to be regarded as standard, values
in parentheses are for
information only.
The following statement pertains only to the test methods and
requirements portion, Section 9, 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.
Keywords:
- elastomer
- expander
- implant
- implant material
- medical device
- plastic surgery
- soft tissue expander
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