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ASTM-F2051:2022 Edition

ASTM-F2051:2022 Edition

$34.13

F2051-00(2022) Standard Specification for Implantable Saline-Filled Breast Prostheses

Published By Publication Date Number of Pages
ASTM 2022
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ASTM F2051-00-Reapproved2022

Active Standard: Standard Specification for Implantable Saline-Filled Breast Prostheses

ASTM F2051

Scope

1.1 This specification covers the requirements for single-use, saline inflatable, smooth and textured silicone shell implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.

1.2 Limitations: 

1.2.1 This specification does not cover custom fabricated implantable breast prostheses.

1.2.2 This specification does not cover gel/saline type implants, which are within the scope of Specification F703.

1.3 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.

1.4 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

breast prosthesis; gel saline prosthesis; implant; saline inflatable prosthesis; silicone elastomer; soft tissue implant;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F2051-00R22

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