F9: Medical Device Alarm System Assessments - Richard Davis - (Intermediate)
This presentation provides the background and overview of the IEC 60601‐1‐8:2006‐10, General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, collateral standard’s approach and associated requirements for medical device alarm systems. It is intended for individuals involved in design conformity assessments to IEC 60601‐1:2010 third edition for legacy products that were developed and marketed prior to the Standard’s introduction and adoption. It covers the key alarm topics of the standard: priority; visual, audible, limits, presets, distributed system and required content of product’s accompanying documents. It provides a systematic methodology of reviewing and evaluating the product and its design, labeling and risk management records to determine the measure of conformity.