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PS 3356-2026
Active
Non-active surgical implants — Mammary implants — Specific requirements
Committee:
Medical Devices and Supplies
Sector:
Health and Personal Care
Available Standards
Original Standard
Not Specified
65
Page
2026
International Classification for Standards (ICS)
| Code | Classification |
|---|---|
| 11.040.40 | Implants for surgery, prosthetics and orthotics |
Adopted Standards
| Standards / Amendment / Corrigendum | |
|---|---|
| 1 | ISO 14607:2024 |
Scope
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.