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I.S. EN ISO 15798:2022

Current

Current

The latest, up-to-date edition.

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

27-02-2022

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

€37.00
Excluding VAT

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Design evaluation
7 Sterilization
8 Product stability
9 Integrity and performance of the delivery system
10 Packaging
11 Information to be supplied by the manufacturer
Annex A (normative) Intraocular implantation test
Annex B (informative) Patient numbers for clinical investigation of intraocular pressure
Annex C (informative) Analyses of OVD clinical data
Bibliography

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.

Committee
ISO/TC 172
DocumentType
Standard
Pages
32
ProductNote
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
ISO 15798:2022 Identical
EN ISO 15798:2022 Identical

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