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ASTM F1441

Standard Specification for Soft-Tissue Expander Devices

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

Document History

ASTM F1441
April 10, 2003
Standard Specification for Soft-Tissue Expander Devices
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...
April 10, 2003
Standard Specification for Soft-Tissue Expander Devices
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...
April 10, 2003
Standard Specification for Soft-Tissue Expander Devices
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...
December 15, 1992
Standard Specification for Soft-Tissue Expander Devices
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. Limitations - This...
December 15, 1992
Standard Specification for Soft-Tissue Expander Devices
1. Scope 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...

References

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