I.S. EN ISO 14155-1:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Justification for a clinical investigation
5 Ethical considerations
6 General requirements
7 Documentation
8 Sponsor
9 Monitor
10 Clinical investigator
11 Final report
Annex A (informative) - Suggested procedure for literature
                        review
Annex B (informative) - Information for the ethics
                        committees
Annex C (informative) - Final reports of clinical
                        investigations
                        with medical devices
Bibliography
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC on Medical
                         Devices
Annex ZB (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 90/385/EEC on Active
                         Implantable Medical Devices

Specifies procedures for the conduct and performance of clinical investigations of medical devices. Applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.