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Glavni meni

ISO 15798:2022

Ophthalmic implants — Ophthalmic viscosurgical devices
17. 1. 2022.

Опште информације

60.60     17. 1. 2022.

ISO

ISO/TC 172/SC 7

Međunarodni standard

11.040.70  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 15798:2013

POVUČEN
ISO 15798:2013/Amd 1:2017

TRENUTNO

OBJAVLJEN
ISO 15798:2022
60.60 Standard objavljen
17. 1. 2022.

Nacionalna preuzimanja

Oftalmološki implantati – Oftalmološka viskoznoelastična hirurška sredstva

60.60   Standard objavljen