M00018148
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ISO FDIS 15798 2012 Edition, November 29, 2012 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES
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Availability date: 07/14/2021
Description / Abstract:
This International Standard is applicable to ophthalmic
viscosurgical devices (OVDs), a class of nonactive 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.
This International Standard 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.