ISO 15798:2022现行
Ophthalmic implants Ophthalmic viscosurgical devices
出版：International Organization for Standardization
专家解读视频
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.
DS/ISO 15798:2022 - Identical
DS/EN ISO 15798:2022 - Identical
EN ISO 15798:2022 - Identical
NS-EN ISO 15798:2022 - Identical
SN EN ISO 15798:2022 - Identical
I.S. EN ISO 15798:2022 - Identical
NF EN ISO 15798:2022 - Identical
