NS EN ISO 11979-9 : 2006 AMD 1 2014
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006/AMD 1:2014)
12-01-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Physical requirements
4.1 General
4.2 Tolerances and dimensions
5 Optical requirements
5.1 General
5.2 Dioptric power
5.3 Imaging quality
5.4 Additional optical characterization
6 Clinical investigation
6.1 General
6.2 Additional requirements for the clinical
investigation plan
7 Information supplied by the manufacturer
Annex A (normative) Optical characterization
Annex B (informative) Clinical investigation
Annex C (informative) Determination of sample sizes
for the clinical investigation
Bibliography
Applies to any intraocular lens whose optic provides two or more rotationally symmetric powers and whose primary indication is the correction of aphakia with the added benefit of useful vision at more than one distance (e.g. far and near).
| DocumentType |
Standard
|
| PublisherName |
Norwegian Standards (Norges Standardiseringsforbund)
|
| Status |
Current
|
| Standards | Relationship |
| I.S. EN ISO 11979-9:2006/A1:2014 | Identical |
| DIN EN ISO 11979-9:2014-12 | Identical |
| UNI EN ISO 11979-9 : 2014 | Identical |
| I.S. EN ISO 11979-9:2006 | Identical |
| ISO 11979-9:2006 | Identical |
| BS EN ISO 11979-9 : 2006 | Identical |
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