ASTM F703 - 18 - Standard Specification for Implantable Breast Prostheses

ASTM F703 - 18

Standard Specification for Implantable Breast Prostheses

Status : Current   Published : February 2018



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.

Standard NumberASTM F703 - 18
TitleStandard Specification for Implantable Breast Prostheses
Publication Date01 February 2018
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Breast prosthesis, gel-saline prosthesis, implant, saline inflatable prosthesis, silicone elastomer, silicone gel prosthesis, soft tissue implant
File Size220 KB

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