ISO 15798:2013

International Standard   Historical · Approved on 02 September 2013

Ophthalmic implants — Ophthalmic viscosurgical devices

ISO 15798:2013 Files

English 16 Pages
Historical
45.77 OMR

ISO 15798:2013 Scope

ISO 15798:2013 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 15798:2013 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.

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