ISO 15798:2022

Ophthalmic implants — Ophthalmic viscosurgical devices

Ophthalmic implants — Ophthalmic viscosurgical devices

Digital Document2022 edition2022Purchase Options

Referenced standards

EN 1041ISO 10993-1ISO 10993-16ISO 10993-6ISO 10993-7ISO 10993-9ISO 11135ISO 11137-1ISO 11137-2ISO 11137-3ISO 11607-1ISO 13408-1ISO 14155ISO 14971ISO 17665-1ISO 22442-1ISO 22442-2ISO 22442-3
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ISO 15798:2022

Ophthalmic implants — Ophthalmic viscosurgical devices

Ophthalmic implants — Ophthalmic viscosurgical devices

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.

Edition2022
Published Date2022
Published ByInternational Standardization Organisation
Page Count19