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
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