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