PLUS 14971 (2003)

Introduction Since the publication in 2000, ISO 14971:2000 has achieved impressive consensus as the world standard for organizations of all types and sizes to follow in implementing and operating a risk management system (RMS) for medical devices. Approved unanimously by the International Electrotechnical Commission (IEC), International Organization for Standardization (ISO), the European Committee for the Coordination of Standards (CEN), and the European Committee for Electrotechnical Standardization (CENELEC), it gives manufacturers of medical devices internationally accepted requirements for RMS that can be used throughout the life cycle of these products. The Standard evolved from a projected family of Standards that began with ISO 14971-1:1998, Risk Analysis. Based on EN 1441, Risk Analysis, Medical Devices, ISO 14971-1 was intended to be the first in a series covering the risk management process. As it became apparent, however, that risk management would be an integral part of several regulatory jurisdictions in the world, including Europe, it was no longer useful or necessary to have a separate standard for risk analysis. Accordingly, ISO 14971-1 was withdrawn when ISO 14971:2000 was published. In Europe, ISO 14971:2000 supersedes EN 1441. EN 1441 will be withdrawn on April 1, 2004.