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ISO 15798:2010

Ophthalmic implants -- Ophthalmic viscosurgical devices

General information
Withdrawn from 02.09.2013
Directives or regulations
None
Standard history
Status
Date
Type
Name
02.09.2013
Main
Main
ISO 15798:2001
Corrigendum
ISO 15798:2001/Cor 1:2003
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.
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