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I.S. EN ISO 15798:2013&A1:2017

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Ophthalmic implants - Ophthalmic viscosurgical devices
Available format(s)

Hardcopy , PDF

Superseded date

10-03-2022

Language(s)

English

Published date

29-10-2017

Preview

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.

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
Bibliography

This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of nonactive surgical implants 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
48
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
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 15798:2013/Amd 1:2017 Identical
EN ISO 15798:2013/A1:2017 Identical

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