99.60 Withdrawal effective Feb 9, 2022
CEN
CEN/TC 170 Ophthalmic optics
European Norm
11.040.70 Ophthalmic equipment
ISO 15798:2013 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery.
ISO 15798:2013 specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.
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WITHDRAWN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 15798:2010
WITHDRAWN
EN ISO 15798:2013
99.60
Withdrawal effective
Feb 9, 2022
WITHDRAWN
EN ISO 15798:2013/A1:2017
PUBLISHED
EN ISO 15798:2022