ASTM F1441 - 03(2014) - Standard Specification for Soft-Tissue Expander Devices

ASTM F1441 - 03(2014)

Standard Specification for Soft-Tissue Expander Devices

Status : Current   Published : January 2014



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.

Standard NumberASTM F1441 - 03(2014)
TitleStandard Specification for Soft-Tissue Expander Devices
Publication Date10 January 2014
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Elastomer, Expander, Implant, Implant material, Medical device, Plastic surgery, Soft tissue expander
File Size90 KB

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