ČSN EN ISO 15798 (195301)

Ophthalmic implants - Ophthalmic viscosurgical devices

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STANDARD published on 1.9.2022


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The information about the standard:

Designation standards: ČSN EN ISO 15798
Classification mark: 195301
Catalog number: 514929
Publication date standards: 1.9.2022
SKU: NS-1071371
The number of pages: 32
Approximate weight : 96 g (0.21 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

The category - similar standards:

Ophthalmic equipment

Annotation of standard text ČSN EN ISO 15798 (195301):

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

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