ISO 15798:2010

Ophthalmic implants — Ophthalmic viscosurgical devices

Ophthalmic implants — Ophthalmic viscosurgical devices

Digital Document2010 edition2010Purchase Options

Referenced standards

EN 980ISO 10993-1ISO 10993-16ISO 10993-2ISO 10993-6ISO 10993-9ISO 11135-1ISO 11137-1ISO 11137-2ISO 11137-3ISO 11607-1ISO 13408-1ISO 14155-1ISO 14155-2ISO 14630ISO 14971ISO 15223-1ISO 15223-2ISO 17665-1ISO 22442-1ISO 22442-2ISO 22442-3
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Ophthalmic implants — Ophthalmic viscosurgical devices

ISO 15798:2010 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 15798:2010 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.

Edition2010
Published Date2010
Published ByInternational Standardization Organisation
Page Count16