prБДС EN IEC 63120:2021

Обновяване/Ремонт на електромедицински апарати, електромедицински системи и подсистеми и повторно използване на компоненти като част от удължения жизнен цикъл

Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle

Обект и област на приложение

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.