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NEN EN ISO 11979-9 : 2006 AMD 1 2014

Current
Current

The latest, up-to-date edition.

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
Published date

01-12-2013

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
Netherlands Standards
Status
Current

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