Standard

NS-EN ISO 14607:2025

Sept 2025 Published

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Abstract

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.

Document information

Standard from SN
Published: 18 September 2025
Edition: 2025-08
Version: 1
Document type: NAT
ISBN:

ICS 11.040.40
National Committee CEN/TC 285

Legal references

EU law: 2017/745

Product Relations

Refers: ISO 37:2024
Refers: ISO 37:2024
Refers: ISO 37:2024
Refers: ISO 34-1:2022
Refers: ISO 34-1:2022
Refers: ISO 34-1:2022
Refers: ISO 48-4:2018
Refers: ISO 48-4:2018
Replaces: NS-EN ISO 14607:2018
Refers: SN-ISO/TS 10993-20:2006
Adopted from: EN ISO 14607:2025

Product life cycle

Previous product

Withdrawn

NS-EN ISO 14607:2018
Current product

Published

NS-EN ISO 14607:2025

NS-EN ISO 14607:2025

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