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SRPS EN ISO 11979-8:2016

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

Aug 30, 2016
95.99   Withdrawal of Standard   Sep 25, 2017

General information

95.99     Sep 25, 2017

ISS

Z172

European Norm

11.040.70  

English  

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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WITHDRAWN
SRPS EN ISO 11979-8/A1:2012

WITHDRAWN
SRPS EN ISO 11979-8:2012

NOW

WITHDRAWN
SRPS EN ISO 11979-8:2016
95.99 Withdrawal of Standard
Sep 25, 2017

REVISED BY

PUBLISHED
SRPS EN ISO 11979-8:2017

Related project

Adopted from EN ISO 11979-8:2015

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

Adopted from ISO 11979-8:2006 IDENTICAL