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.
Document identifier
ISO 15798:2013
Title
Ophthalmic implants - Ophthalmic viscosurgical devices
ISO Category
TC 172/SC 7: Ophthalmic optics and instruments
Publication date
2013-09-15
International Relationship
BS EN ISO 15798:2013 * DIN EN ISO 15798
History of version
ISO 15798:2013 * ISO 15798:2010 * ISO 15798:2001
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103 vnd |
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