NS EN 540 : 1ED 1993

Cooperating organizations
National foreword
Foreword
0. Introduction
1. Scope
2. Normative references
3. Terminology and definitions
4. General requirements
5. Methodology
6. Presentation of results
Annex A (informative) Bibliography
National annex NA (informative) Committees responsible

Defines procedures to help manufacturers, regulatory authorities, sponsors and clinical investigators on the conduct and performance of the clinical investigation of medical devices. Also includes terminology and definitions.