Table of Contents
Abstract
Identifies fundamental considerations to be taken into account in developing Standards to ensure the safety of medical electrical equipment. It also provides a guide to the strategies and methodologies used in developing the IEC 601 and AS/NZS 3200 series of Standards. It is identical with and reproduced from IEC 513:1994.
Scope
This report identifies fundamental considerations to be taken into account in developing standards to ensure the safety of medical electrical equipment.
NOTE - This report follows closely recommendations of ISO/IEC Guide 51* and expands on matters which are unique to, or critical in, the application of medical electrical equipment.
This report is primarily intended to be used by:
those who prepare standards for the design, installation and use of medical electrical equipment;
health care regulatory authorities, test houses and other organizationsresponsible for implementing standards for medical electrical equipment;
manufacturers of medical electrical equipment;
those who assemble systems which include medical electrical equipment.
This report may also be of assistance to:
users or operators of medical electrical equipment;
hospital administrators;
non-technical personnel involved in the procurement of medical electrical equipment;
educators and students.
hospital and clinical engineersresponsible for the construction of patient care facilities or for the procurement or maintenance of medical electrical equipment;
History
First published as Joint Standard AS/NZS 4513:1995.