Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk assessment
5 Pilot clinical studies
6 Clinical validation investigation
Annex A (informative) - Formula for Power Calculation
Annex B (informative) - Pilot Clinical Investigation
Annex C (informative) - Time and Events Schedule for individual
study subject (sample)
Annex D (informative) - Study Entry, data collection form
Annex E (informative) -Mid-study, data collection form
Annex F (informative) - Single Use of Female Condom, data
collection form
Annex G (informative) - Advert reaction report form (sample)
Annex H (informative) - Protocol for Evaluation of Returned
Used Condoms
Bibliography