Foreword
1 Scope and purpose
2 Normative references
3 Definitions
4 Physical requirements
5 Optical requirements
6 Mechanical requirements
7 Biocompatibility requirements
8 Sterility/package integrity requirements
9 Shelf-life and transport stability
10 Clinical investigation plan
11 Labeling
Annexes
Annex A - Mechanical characterization and testing
of phakic IOLs
Annex B - Non-ocular implantation test
Annex C - Ocular implantation test
Annex D - Clinical guidance
Annex E - Statistical sample size considerations
Annex F - Bibliography