DANSK DSF/PREN IEC 63120 PDF

This document describes the REFURBISHMENT PROCESS following risk management concepts for the REFURBISHMENT of MEDICAL ELECTRICAL EQUIPMENT (MEE), MEDICAL ELECTRICAL SYSTEMS (MES) – which are covered by the IEC 60601 series of standards – or SUB-ASSEMBLIES and the RE-USE of COMPONENTS as a possibility for an extended life cycle for MEE/MES. Applying this PROCESS to used MEE/MES and SUB-ASSEMBLIES as defined in this document ensures compliance to BASIC SAFETY and ESSENTIAL PERFORMANCE of the refurbished MEE and MES including their SUB-ASSEMBLIES. This document also covers REFURBISHED SUB-ASSEMBLIES for re-use during the EXTENDED LIFE CYCLE of ME EQUIPMENT and ME SYSTEMS, and RE-USE of used COMPONENTS. This document does not cover - medical imaging equipment in the scope of IEC 63077:2019, including their SUB-ASSEMBLIES and COMPONENTS; - repair, maintenance and servicing of ME EQUIPMENT or ME SYSTEM covered by IEC 60601-1 and IEC 62353; - unauthorized modification of ME EQUIPMENT or ME SYSTEM or parts of such equipment/systems; - environmental conscious design covered by IEC 60601-1-9 or IEC 62430; - environmental aspects covered by the ISO TC 207 standards and waste treatment covered by IEC TC 111 standards; - REFURBISHMENT of limited multiple use devices or parts of such devices; - REFURBISHMENT of single use devices or parts of such devices; - REFURBISHMENT of COMPONENTS.