BS 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.

This part of ISO 14155 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to protect human subjects, ensure the scientific conduct of the clinical investigation, assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices. This part of ISO 14155 specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device, specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device, is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects. This part of ISO 14155 is not applicable to in vitro diagnostic medical devices.