ASTM-F1441 Standard Specification for Soft-Tissue Expander Devices

ASTM-F1441 - 2003 R14 EDITION - CURRENT
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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. 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. The device shall be classified as: Type I; Type II; and Type III. Biocompatibility, tensile set, breaking force, tubing shell junction, injection port competence, overexpansion, tubing length adapter strength, needle stop penetration, and fused or adhered joints tests shall be performed to conform with the specified requirements.

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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 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.

Keywords

elastomer; expander; implant; implant material; medical device; plastic surgery; soft tissue expander;; ICS Number Code 85.100 (Equipment for the paper industry)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

85.100 (Equipment for the paper industry)

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Document Number

ASTM-F1441-03(2014)

Revision Level

2003 R14 EDITION

Status

Current

Modification Type

Reapproval

Publication Date

Dec. 1, 2014

Document Type

Specification

Page Count

5 pages

Committee Number

F04.32