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ASTM F2051-00(2006)
Standard Specification for Implantable Saline Filled Breast Prosthesis
STANDARD published on 1.9.2006
The information about the standard:
Designation standards: ASTM F2051-00(2006)
Note: WITHDRAWN
Publication date standards: 1.9.2006
SKU: NS-52601
The number of pages: 6
Approximate weight : 18 g (0.04 lbs)
Country: American technical standard
Category: Technical standards ASTM
Annotation of standard text ASTM F2051-00(2006) :
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 | ||||||||||||||
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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 F 703. 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. |
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| 2. Referenced Documents | ||||||||||||||
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