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EN ISO 11979-8:2015

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd 1:2011) EN ISO 11979-8:2015

Publication date:   Apr 21, 2015

General information

99.60 Withdrawal effective   May 10, 2017

CEN

CEN/TC 170 Ophthalmic optics

European Norm

11.040.70   Ophthalmic equipment

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Scope

11979-8:2006 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

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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

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Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 11979-8:2009

WITHDRAWN
EN ISO 11979-8:2009/A1:2011

NOW

WITHDRAWN
EN ISO 11979-8:2015
99.60 Withdrawal effective
May 10, 2017

REVISED BY

PUBLISHED
EN ISO 11979-8:2017

Relations

Adopted from ISO 11979-8:2006 IDENTICAL

Adopted from ISO 11979-8:2006/Amd 1:2011 IDENTICAL