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ASTM F703-18(2022)

Historical Reaffirmation

Standard Specification for Implantable Breast Prostheses

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

1.2 Limitations—This specification does not cover custom fabricated implantable breast prostheses.

1.3 Single-use saline-inflatable, smooth and textured silicone shell implantable breast prostheses are addressed in Specification F2051.

1.4 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.

1.5 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.

1.6 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.


This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast. Breast prosthesis are classified into three types: type I breast prosthesis, n - implantable breast prosthesis containing a single lumen containing a fixed amount of silicone gel, Type II breast prosthesis, n - implantable breast prosthesis comprised of two complete lumens, one inside the other, and type III breast prosthesis, n - implantable breast prosthesis comprised of two complete lumens, one inside the other. Elongation, breaking strength, tensile set, critical fused or adhered joints, shell rupture, and shell leakage shall be tested to meet the requirements prescribed. Gel cohesion, gel bleeding, and gel penetration shall be tested to meet the requirements prescribed.


SDO ASTM: ASTM International
Document Number F703
Publication Date Oct. 1, 2022
Language en - English
Page Count 10
Revision Level 18(2022)
Supercedes
Committee F04.32
Publish Date Document Id Type View
Feb. 1, 2018 F0703-18 Revision
April 1, 2007 F0703-07 Revision
June 10, 1996 F0703-96R02E01 Revision
Jan. 1, 1996 F0703-96 Revision
Oct. 1, 2022 F0703-18R22 Reaffirmation
June 10, 1996 F0703-96R02 Reaffirmation