NEN EN ISO 11979-10 : 2006 AMD 1 2014
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES
12-01-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Optical requirements
4.1 General
4.2 Dioptric power
4.3 Imaging quality
4.4 Spectral transmittance
5 Mechanical requirements
6 Clinical investigation
6.1 General
6.2 Clinical assessments
6.3 Other considerations
7 Information supplied by the manufacturer
Annex A (informative) Clinical investigation
Annex B (informative) Statistical sample size
considerations
Bibliography
Applies to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye but excludes phakic IOLs (PIOLs) that utilize multifocal or other simultaneous vision optics to address presbyopic loss of accommodation and PIOLs that correct astigmatism.
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| SupersededBy |
| Standards | Relationship |
| UNE-EN ISO 11979-10:2007 | Identical |
| DIN EN ISO 11979-10:2014-12 | Identical |
| UNI EN ISO 11979-10 : 2015 | Identical |
| I.S. EN ISO 11979-10:2007 | Identical |
| ONORM EN ISO 11979-10 : 2014 | Identical |
| EN ISO 11979-10:2018 | Identical |
| ISO 11979-10:2006 | Identical |
| BS EN ISO 11979-10 : 2006 | Identical |
| SN EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| NBN EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| NS EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| NF EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
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