ASTM International - ASTM F703-18
Standard Specification for Implantable Breast Prostheses
| Organization: | ASTM International |
| Publication Date: | 1 February 2018 |
| Status: | inactive |
| Page Count: | 10 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
1.1 This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.
1.2 Limitations-This
1.3 Single-use saline-inflatable, smooth, and textured silicone shell implantable breast prostheses are addressed in Specification F2051.
1.4 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.
1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
abstract:
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone.... View More
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