EN ISO 11979-8:2017

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)

Publication date:   Sep 20, 2017

General information

60.60 Standard published   May 10, 2017

CEN

CEN/TC 170 Ophthalmic optics

European Norm

11.040.70   Ophthalmic equipment

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Scope

ISO 11979-8:2017 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

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

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 11979-8:2015

NOW

PUBLISHED
EN ISO 11979-8:2017
60.60 Standard published
May 10, 2017