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EN ISO 14607:2009

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007) EN ISO 14607:2009

Publication date:   Aug 20, 2010

General information

99.60 Withdrawal effective   May 16, 2018

CEN

CEN/TC 285 Non-active surgical implants

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

ISO 14607:2007 specifies particular requirements for mammary implants for clinical practice.
With regard to safety, ISO 14607:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging 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WITHDRAWN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 14607:2007

NOW

WITHDRAWN
EN ISO 14607:2009
99.60 Withdrawal effective
May 16, 2018

REVISED BY

PUBLISHED
EN ISO 14607:2018

Relations

Adopted from ISO 14607:2007 IDENTICAL