This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices 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 document 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.
EN ISO 15798:2022 history
2022EN ISO 15798:2022 Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
2013EN ISO 15798:2013 Ophthalmic implants - Ophthalmic viscosurgical devices
2010EN ISO 15798:2010 Ophthalmic implants - Ophthalmic viscosurgical devices
2001EN ISO 15798:2001 Ophthalmic Implants - Ophthalmic Viscosurgical Devices Incorporating corrigendum March 2005