I.S. EN ISO 16672:2021
Current
The latest, up-to-date edition.
Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)
Hardcopy , PDF
English
31-10-2021
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.
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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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