ASTM F2051 - 00(2014) - Standard Specification for Implantable Saline Filled Breast Prosthesis

ASTM F2051 - 00(2014)

Standard Specification for Implantable Saline Filled Breast Prosthesis

Status : Current   Published : January 2014



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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard NumberASTM F2051 - 00(2014)
TitleStandard Specification for Implantable Saline Filled Breast Prosthesis
Publication Date10 January 2014
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, Soft tissue implant
File Size98 KB

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