Tagasi

prEN ISO 15798

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO/DIS 15798:2020)

Üldinfo
Kavand
Alusdokumendid
ISO/DIS 15798; prEN ISO 15798
Tegevusala (ICS grupid)
11.040.70 Silmaraviseadmed
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
Põhitekst
01.11.2017
Muudatus
14.11.2013
Põhitekst
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.
*
*
*
PDF
5,40 € koos KM-ga
Paber
5,40 € koos KM-ga
Standardi monitooring