IEC TR 60601-4-9 ED1

Medical electrical equipment - Part 4-9: Guidance and interpretation - Maintaining essential performance in single fault condition - Examples

Scope

IEC TR 60601-4-9:2025 applies to medical electrical equipment (mee) and medical electrical systems (mes). It provides examples of a systematic approach for maintaining essential performance in single fault condition according to subclauses 4.3, 4.7 and 5.1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
This document is intended to be used by the following stakeholders:
– mee/mes manufacturers;
– mee/mes designers;
– testing laboratories;
– responsible organizations;
– regulators;
– standards developers;
– other interested parties.
Internal faults of components (including pess) or subassemblies of an mee are within the scope of this document. Faults of interconnections in an mes between one or more mee and further equipment are also within the scope of this document.
External faults or abnormal conditions with regard to the mee or mes (such as loss of external power or gas supplies, misuse in other than the specified environmental conditions, security breaches into the mee or mes, faults within data transmission lines external to an mee or mes) are also to be considered by manufacturers for a safe design of mee/mes but are not dealt with in this document; they are, therefore, outside of the scope of this document.