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NEN EN ISO 11979-10 : 2006 AMD 1 2014

Current

Current

The latest, up-to-date edition.

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES

Published date

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

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