EN ISO 14607:2018

Name: EN ISO 14607:2018
Brand: CEN
SKU: EN ISO 14607:2018
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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

Current stage: 99.60 Withdrawal effective Aug 27, 2025

Originator: CEN

Owner: CEN/TC 285 Non-active surgical implants

Type: European Norm

ICS: 11.040.40 Implants for surgery, prosthetics and orthotics

Buying

Status: Withdrawn

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

Harmonised Standard / Cited in the Official Journal

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WITHDRAWN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

WITHDRAWN
EN ISO 14607:2018
99.60 Withdrawal effective
Aug 27, 2025

REVISED BY

PUBLISHED
EN ISO 14607:2025