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.
