DIN EN ISO 14155-1 E : 2003

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>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;review<br>Annex B (informative) - Information for the ethics<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;committees<br>Annex C (informative) - Final reports of clinical<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;investigations with medical devices<br>Bibliography<br>Annex ZA (informative) - Relationship between this European<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Standard and the Essential Requirements<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of EU Directive 93/42/EEC on Medical Devices<br>Annex ZB (informative) - Relationship between this European<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Standard and the Essential Requirements of EU <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Directive 90/385/EEC on Active Implantable Medical <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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.