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FprEN ISO 14607

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

Publication date:   Aug 10, 2023

General information

60.55 Ratification completed (DOR)   Oct 17, 2024

CEN

CEN/TC 285 Non-active surgical implants

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

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Draft

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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.

Related legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Legislation 2017/745

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 14607:2018

NOW

IN_DEVELOPMENT
FprEN ISO 14607
60.55 Ratification completed (DOR)
Oct 17, 2024