scope:

This document provides guidance to MANUFACTURERS of MEDICAL ELECTRICAL EQUIPMENT (MEE) and MEDICAL ELECTRICAL SYSTEMS (MES) that generate ALARM CONDITIONS and/or ALARM SIGNALS to meet the requirements for logging of ALARM SYSTEM data and support investigative activities performed by MANUFACTURERS and RESPONSIBLE ORGANIZATIONS.

This document is not intended to provide guidance for a product feature used by clinicians while caring for a PATIENT that stores physiological PATIENT data (waveform and numeric parameter data) or ALARM CONDITIONS. While this type of data is important, it is not considered RESPONSIBLE ORGANIZATION ALARM SYSTEM LOG data and is outside the scope of this document.