Name: ASTM F 1441 : 2003 : R2014
Brand: ASTM
Price: 75.00 USD

ASTM F 1441 : 2003 : R2014

Superseded

View Superseded by

Standard Specification for Soft-Tissue Expander Devices

Available format(s)

Hardcopy , PDF

Superseded date

10-14-2022

Language(s)

English

Published date

11-27-2014

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2015 Describes 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.

1.1This 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.

1.2Limitations:

1.2.1This 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.

1.2.2This specification applies, in part, to combination “expander/mammary” devices as classified in Section 4.

1.3The values stated in SI units are to be regarded as standard, values in parentheses are for information only.

1.4The 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.

Committee	F 04
DocumentType	Standard
Pages	5
ProductNote	Reconfirmed 2014
PublisherName	American Society for Testing and Materials
Status	Superseded
SupersededBy	ASTM F 1441 : 2003 : R2022
Supersedes	ASTM F 1441 : 2003 : R2009

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