ANSI/AAMI EQ103:2024

This standard provides a framework for the development and ongoing management of an AEM program. The standard assists Healthcare Delivery Organizations (HDOs) seeking to meet the related Conditions of Participation set by the Centers for Medicare and Medicaid Services (CMS). By incorporating a quantitative, scientific, and risk-based methodology, along with input from clinical staff, this standard establishes minimum requirements for AEM programs. For devices included in an AEM program, this standard provides requirements for procedures that assure acceptable levels of safety and performance are maintained. No annex