1888004

ASTM F1441-03(2014)

Standard Specification for Soft-Tissue Expander Devices

standard by ASTM International , 10/01/2014

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About This Item

 

Full 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.

 

Product Details

Published:
10/01/2014
Number of Pages:
5
File Size:
1 file , 90 KB
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. ASTM F1441-03(2022)


    Standard Specification for Soft-Tissue Expander Devices

    • Most Recent

  2. ASTM F1441-03(2014)

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    Standard Specification for Soft-Tissue Expander Devices

    • Historical Version

  3. ASTM F1441-03(2009)


    Standard Specification for Soft-Tissue Expander Devices

    • Historical Version

  4. ASTM F1441-03


    Standard Specification for Soft-Tissue Expander Devices

    • Historical Version

  5. ASTM F1441-92(2002)


    Standard Specification for Soft-Tissue Expander Devices

    • Historical Version

  6. ASTM F1441-92(1998)


    Standard Specification for Soft-Tissue Expander Devices

    • Historical Version