ASTM F2051-00(2014)

Standard Specification for Implantable Saline Filled Breast Prosthesis

STANDARD published on 1.10.2014

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The information about the standard:

Designation standards: ASTM F2051-00(2014)
Note: WITHDRAWN
Publication date standards: 1.10.2014
SKU: NS-52602
The number of pages: 6
Approximate weight : 18 g (0.04 lbs)
Country: American technical standard
Category: Technical standards ASTM

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The category - similar standards:

Implants for surgery, prosthetics and orthotics

Annotation of standard text ASTM F2051-00(2014) :

Keywords:

breast prosthesis, gel saline prosthesis, implant, saline inflatable prosthesis, silicone elastomer, soft tissue implant,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

1. Scope

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.

2. Referenced Documents

D412-16(2021)	Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
F1251-89(1995)	Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F703-18(2022)	Standard Specification for Implantable Breast Prostheses
F604-94	Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
D1349-14(2019)	Standard Practice for Rubber´Standard Conditions for Testing
D3389-21	Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)

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