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ONORM EN ISO 15798:2022
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
This document is applicable to ophthalmic viscoelastic substances (OVD, en: Ophthalmic Viscosurgical Devices), a class of surgical invasive medical devices with viscoses and/or viscoelastic properties that are intended for use in surgical interventions in the front of the human eye. Ovds are used to create and maintain space, protect intraocular tissue and manipulate tissue during the surgical intervention. This document determines requirements regarding the security for the intended service, construction features, pre -clinical and clinical reviews, sterilization, product packaging, product identification and providing information from the manufacturer of these products.
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Austrian Standards Institute [on]