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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.
Reģistrācijas numurs (WIID)
69702
Darbības sfēra
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.
