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dnaSRPS EN ISO 14607:2022

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

General information

50.60     Sep 16, 2024

ISS

Z076

European Norm

11.040.40  

English  

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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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

Life cycle

PREVIOUSLY

PUBLISHED
SRPS EN ISO 14607:2018

NOW

PROJECT
dnaSRPS EN ISO 14607:2022
50.60 Close of voting. Proof returned by secretariat
Sep 16, 2024

Related project

Adopted from EN ISO 14607:2025 IDENTICAL

Adopted from ISO 14607:2024 IDENTICAL