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ASTM F2051 : 00

Standard Specification for Implantable Saline Filled Breast Prosthesis

Standard Details

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 F703 (Standard Specification for Implantable Breast Prostheses).

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.

General Information

Status : Historical
Standard Type: Main
Document No: ASTM F2051 : 00
Document Year: 2000
Pages: 6
  • Section Volume:
  • 13.01 Volume 13.01 Medical and Surgical Materials and Devices (I): E667 - F2477
  • ICS:
  • 11.040.40 Implants for surgery, prosthetics and orthotics

Life Cycle

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ASTM F2051 : 00
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