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ASTM International - ASTM F1441-03

Standard Specification for Soft-Tissue Expander Devices

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Organization: ASTM International
Publication Date: 10 April 2003
Status: inactive
Page Count: 5
ICS Code (Equipment for the paper industry): 85.100
scope:

1.1 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.

1.2 Limitations:

1.2.1 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.

1.2.2 This specification applies, in part, to combination "expander/mammary" devices as classified in Section 4.

1.3 The values stated in SI units are to be regarded as standard, values in parentheses are for information only.

1.4 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.

abstract:

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... View More

Document History

October 1, 2014
Standard Specification for Soft-Tissue Expander Devices
1.1 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...
April 1, 2009
Standard Specification for Soft-Tissue Expander Devices
1.1 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...
ASTM F1441-03
April 10, 2003
Standard Specification for Soft-Tissue Expander Devices
1.1 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...
October 10, 1998
Standard Specification for Soft-Tissue Expander Devices
1.1 This specification covers the requirements for inflatable tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed. 1.2 Limitations...
December 15, 1992
Standard Specification for Soft-Tissue Expander Devices
1.1 This specification covers the requirements for inflatable tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed. 1.2 Limitations—This...
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