ASTM-F1441:2009 Edition

$40.63

F1441-03(2009) Standard Specification for Soft-Tissue Expander Devices

Published By	Publication Date	Number of Pages
ASTM	2009	5

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Category: ASTM

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Description

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.

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
2	Classification Significance and Use Volume and Dimensions Fixation Sites Orientation Means Test Methods and Requirements
3	FIG. 1
4	Sterilization Packaging, Labelling, and Package Inserts Keywords X1. RATIONALE X1.1 X1.2 X1.3 X1.4
5	X1.5 X1.6