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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