Standard Historical Last Updated: Aug 16, 2017 Track Document
ASTM F1441-92(2002)

Standard Specification for Soft-Tissue Expander Devices

Standard Specification for Soft-Tissue Expander Devices F1441-92R02 ASTM|F1441-92R02|en-US Standard Specification for Soft-Tissue Expander Devices Standard new BOS Vol. 13.01 Committee F04
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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 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.

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 portion, Section 7, of this specification.This standard does not purport to address all of the safety problems, 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.

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Details
Book of Standards Volume: 13.01
Developed by Subcommittee: F04.32
Pages: 4
DOI: 10.1520/F1441-92R02
ICS Code: 85.100