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EN ISO 14607:2025 Standard

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  Keywords:

#specifies #document #implants #design #manufacturer

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Thursday 11th of June 2026

  Description:

Non-active surgical implants - Mammary implants - Specific requirements (ISO 14607:2024)

  Purpose

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.

  Publication

Thursday 11th of June 2026

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