SN EN ISO 11979-10 : 2006 AMD 1 2014

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.