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

Format
PDF

Format
HARDCOPY



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
StatusCurrent
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
ICS11.040.40
PublisherASTM
FormatA4
DeliveryYes
Pages6
File Size98 KB
Price£40.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Worldwide Standards
We can source any standard from anywhere in the world


Develop a PAS

Develop a fast-track standardization document in 9-12 months