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I.S. EN ISO 16672:2021

Current

Current

The latest, up-to-date edition.

Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-10-2021

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 supplied by the manufacturer
Annex A (normative) Intraocular implantation test
Annex B (informative) Clinical investigation
Annex C (informative) Method for quantifying incompletely fluorinated contaminants in perfluorocarbon liquids
Bibliography

This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.

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 16672:2020 Identical
EN ISO 16672:2021 Identical

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