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EN ISO 14607:2018

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08) EN ISO 14607:2018

Publication date:   Sep 18, 2018

General information

60.60 Standard published   May 16, 2018

CEN

CEN/TC 285 Non-active surgical implants

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

Buying

Published

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Scope

ISO 14607:2018 specifies particular 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

93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Legislation 2007/47/EC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 14607:2009

NOW

PUBLISHED
EN ISO 14607:2018
60.60 Standard published
May 16, 2018

REVISED BY

IN_DEVELOPMENT
FprEN ISO 14607