Clause 1 – Scope, object and related standards

This collateral standard provides the general requirements for the implementation of ALARM SYSTEMS in ME EQUIPMENT and ME SYSTEMS to provide information necessary for the safety of PATIENTS, OPERATORS and others involved with PATIENT care. As the urgency of the OPERATOR'S attention is dependent on the cause of the ALARM CONDITION, this collateral standard specifies ALARM CONDITION priorities and their ALARM SIGNAL characteristics so that the OPERATOR can perceive the urgency of the situation and the necessary action independent of the type, brand, etc. of the ME EQUIPMENT that is generating ALARM SIGNALS. [13], [14], [15], [16] In addition, a standardized unambiguous ALARM SYSTEM vocabulary is presented as a means to improve PATIENT safety that will be used in ME EQUIPMENT and ME SYSTEM design and markings as well as in the ACCOMPANYING DOCUMENTS.

Because this standard applies equally to simple INTERNAL ELECTRICAL POWER SOURCE operated or home-care ME EQUIPMENT as well as complex LIFE-SUPPORTING ME EQUIPMENT, it has not been possible to provide specific requirements for many important issues. Particular standards should provide, as appropriate, more detailed requirements for their equipment category. The nomenclature and basic requirements of this standard should ensure a consistent approach for ALARM SYSTEMS across a wide range of equipment types.