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