ISO 15798:2022

ISO 15798:2022

January 2022
International standard Current

Ophthalmic implants - Ophthalmic viscosurgical devices

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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Main informations

Collections

International ISO standards

Publication date

January 2022

Number of pages

20 p.

Reference

ISO 15798:2022

ICS Codes

11.040.70   Ophthalmic equipment

Print number

1
Sumary
Ophthalmic implants - Ophthalmic viscosurgical devices

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.

Replaced standards (2)
ISO 15798:2013
September 2013
International standard Cancelled
Ophthalmic implants - Ophthalmic viscosurgical devices

ISO 15798:2013 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants 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 intra-ocular tissues and to manipulate tissues during surgery. ISO 15798:2013 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.

ISO 15798/A1:2017
May 2017
International standard Cancelled
Draft amendment 1 to standard ISO 15798:2013

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