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Standard Specification for Implantable Saline-Filled Breast Prostheses
1.1 This specification covers the requirements for saline inflatable silicone shell implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.
1.2 This specification does not cover saline inflatable silicone gel-filled implants and non-inflatable silicone gel-filled implants that are within the scope of Specification F703 or soft tissue expander devices that are within the scope of Specification F1441.
1.3 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.
1.4 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.
1.5 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.
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