NEN EN ISO 11979-3 : 2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 General
  4.2 Tolerances and dimensions
  4.3 Clearance analysis
  4.4 Compression force
  4.5 Axial displacement in compression
  4.6 Optic decentration
  4.7 Optic tilt
  4.8 Angle of contact
  4.9 Compression force decay
  4.10 Dynamic fatigue durability
  4.11 Surgical manipulation
  4.12 Surface and bulk homogeneity
5 Recovery of properties following simulated surgical
  manipulation
Annex A (normative) Measurement of compression force
Annex B (normative) Measurement of axial displacement in
        compression
Annex C (normative) Measurement of optic decentration
Annex D (normative) Measurement of optic tilt
Annex E (normative) Measurement of angle of contact
Annex F (normative) Testing of compression force decay
Annex G (normative) Testing of dynamic fatigue durability
Annex H (informative) Measurement of loop pull strength
Annex I (informative) Clearance analysis
Annex J (informative) Precision
Bibliography

Defines requirements and test methods for certain mechanical properties of intraocular lenses (IOLs). Pertains to all types of IOLs intended for implantation in the anterior segment of the human eye, excluding corneal implants, provided that the test method is appropriate to the particular IOL design.