Norm

ASTM F2051-00(2014)

Standard Specification for Implantable Saline Filled Breast Prosthesis

54,27

Over deze norm

Status Definitief
Aantal pagina's 6
Commissie F04.32
Gepubliceerd op 01-10-2014
Taal Engels

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.

Details

ICS-code 11.040.40
Nederlandse titel Standard Specification for Implantable Saline Filled Breast Prosthesis
Engelse titel Standard Specification for Implantable Saline Filled Breast Prosthesis

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