Full Description BS EN ISO 15798:2013+A1:2017 is applicable to ophthalmic viscosurgical devices (OVDs), a class of nonactive 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 intraocular tissues and to manipulate tissues during surgery.
This International Standard 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.
Cross References:
EN 1041
ISO 14155
ISO 11137-1
ISO 10993-16
ISO 22442-2
ISO 22442-1
ISO 22442-3
ISO 11135-1
EN 980
ISO 10993-1
ISO 11607-1
ISO 10993-9
ISO 11137-2
ISO 15223-1
ISO 10993-2
ISO 10993-6
ISO 15223-2
ISO 14971
ISO 13408-1
ISO 14630
ISO 11137-3:2017
ISO 17665-1
Incorporates the following:
Amendment, February 2018