ASTM-F1441:2022 Edition

$34.13

F1441-03(2022) Standard Specification for Soft-Tissue Expander Devices

Published By	Publication Date	Number of Pages
ASTM	2022	5

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Category: ASTM

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Description

ASTM F1441-03-Reapproved2022

Active Standard: Standard Specification for Soft-Tissue Expander Devices

ASTM F1441

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 six 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Keywords

elastomer; expander; implant; implant material; medical device; plastic surgery; soft tissue expander;

ICS Code

ICS Number Code 85.100 (Equipment for the paper industry)

DOI: 10.1520/F1441-03R22

Additional information