This guide targets customers of alarm systems. It may help customers to evaluate the risks involved in the operation of alarm system, typically attributed to user errors. Hopefully, in the future this guide will be formulated as a standard for customers of alarm systems.
This guide focuses on the usability of alarm system. It does not replace IEC 60601-1-8, which after fixing major usability mistakes, may be suitable for guiding the manufacturers in the system design.
The Audience |
This guide is intended for use by people in medical operational systems, in hospitals or at home, who need to purchase a medical equipment or a medical system, equipped with alarming facilities. |
When to use |
This guide may be used in any event of purchasing a new medical equipment or system that implements alarming facilities, to notify the user of risky situations. Before purchasing the system, the users may verify that the manufacturer is familiar with this guide and that the equipment confirms with this guide. |
Scope |
This guide is complementary to the international standard IEC 60601-1-8. Practically, it is a list of recommendations for the customers of the equipment about how to evaluate it, in a way that will minimize the risks of missing important alarms. |
Motivation |
The Usability Technical Committee 1817 of the Israeli Institute of Standards (SII) sought to adapt the international standard, hoping to recommend it to the SII as the standard for Israeli medical systems, as well as for Israeli customers of medical systems. The committee evaluated the international standard and realized that it describes adequately most of the usability problems typical to ME operation, but does not provide adequate solutions to these problems. Eventually, it became clear that the standard is not adequate for users in medical facilities (more on the need for this guide). |
About IEC 60601-1-8 |
IEC 60601-1-8 is an international standard for alarm systems in medical electrical equipment and medical electrical systems (ME). It is part of IEC-60601-1, which is about general requirements for basic safety and essential performance of ME. The standard may be found in http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=37404 |