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  • BSI
    BS EN ISO 15798:2022 Ophthalmic implants. Ophthalmic viscosurgical devices
    Edition: 2022
    $435.35
    / user per year

Description of BS EN ISO 15798:2022 2022

This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices 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 intraocular tissues and to manipulate tissues during surgery. This document 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.

Standard NumberBS EN ISO 15798:2022
TitleOphthalmic implants. Ophthalmic viscosurgical devices
StatusDefinitive
Publication Date2022-07-19
ReplacesBS EN ISO 15798:2013, BS EN ISO 15798:2013+A1:2017
Identical National Standard OfEN ISO 15798, ISO 15798
DescriptorsImplants (surgical), Medical equipment, Ophthalmology, Ophthalmic test equipment, Surgical equipment, Ophthalmic equipment, Medical instruments, Contact lenses
ICS11.040.70 Ophthalmic equipment
CommitteeCH/172/7
ISBN978 0 539 12121 6
PublisherBSI
Pages32

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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