Recognized standard
14607 Fourth edition 2024-12
FDA recognition 6-513 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-513 |
|---|---|
| Designation | 14607 Fourth edition 2024-12 |
| Title | Non-active surgical implants - Mammary implants - Specific requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 26, 2025 |
| Device classes | Class 3 |
| Scope (excerpt) | This document specifies specific requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization and information supplied by the manufacturer. |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: