99.60 Withdrawal effective Nov 25, 2020
CEN
CEN/TC 170 Ophthalmic optics
European Norm
11.040.70 Ophthalmic equipment
ISO 15004-1:2006 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. ISO 15004-1:2006 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.
ISO 15004-1:2006 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.
Legislation related to this standard
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
WITHDRAWN
EN ISO 15004-1:2006
WITHDRAWN
EN ISO 15004-1:2009
99.60
Withdrawal effective
Nov 25, 2020
PUBLISHED
EN ISO 15004-1:2020