BH GSO ISO 15798:2022
ISO 15798:2013
Bahraini Standard
Current Edition
·
Approved on
28 April 2022
Ophthalmic implants — Ophthalmic viscosurgical devices
BH GSO ISO 15798:2022 Files
English
16 Pages
Current Edition
Reference Language
BHD
45.28
BH GSO ISO 15798:2022 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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