Foreword
1 Scope and purpose
2 Normative references
3 Definitions
4 Mechanical, thermal, and environmental requirements
5 Safety requirements
6 Optical requirements
7 System control and performance
8 Clinical evaluation
9 Test methods
10 Accompanying documents
11 Marking
Annexes
Annex A - Spectral weighting function for ultraviolet radiation
hazard analysis
Annex B - Methods for system calibration
Annex C - Characterization of laser ablation beams and treatment
patterns
Annex D - Guidance on clinical study design of refractive
procedures that use laser systems for corneal reshaping
Annex E - Statistical sample size considerations
Annex F - Presentation of results of clinical studies
Annex G - Bibliography