21/30406209 DC

This standard 21/30406209 DC BS EN ISO 15798. Ophthalmic implants. Ophthalmic viscosurgical devices is classified in these ICS categories:

• 11.040.70 Ophthalmic equipment

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.