A Revised Guideline for Medical Device Clinical Investigations: ISO 14155 Part 1 and 2: 2003

Abstract

The international standard (International Organization for Standardization (ISO)) ISO 14155:1996 'Clinical Investigation of Medical Devices for Human Subjects' has been updated in 2003. The revised ISO 14155:2003 focuses on general requirements for clinical studies (Part 1) and the clinical investigation plan (Part 2). The documents provide manufacturers with significantly improved guidelines for the conduct of clinical investigations with medical devices. This article highlights the main differences between the previous version of 1996 and the new version of 2003. The article also points out some areas in the new ISO 14155 which may still need further improvement. Copyright © 2004 John Wiley & Sons, Ltd.