BS EN IEC 63077:2019 pdf download.Good refurbishment practices for medical imaging equipment.
4.2 Resource management
The REFURBISHER shall determine, and provide adequate resources,including:trained and qualified personal;
maintained and calibrated equipment;
instructions,procedures, files, records, or documents to perform the REFURBISHMENT; andan environment for REFURBISHMENT that is in compliance with the applicable environmental,occupational health and safety requirements.
4.3 corrective and preventive action
The REFURBISHER shall implement a comprehensive corrective action and preventive action(CAPA) PROcEss，addressing the specific aspects of the REFURBISHMENT of usED MEDICALIMAGING EQUIPMENT.
In addition，in the event that the REFURBISHER identifies，through its CAPA system,safetyrelated issues that are the responsibility of the original MANUFACTURER and not related to theREFURBISHMENT, it shall inform the original MANUFACTURER accordingly.
4.4 customer complaints
The REFURBISHER shall have in place a system for managing complaints.
ln addition，the REFURBISHER shall communicate to the original MANUFACTURER all customercomplaints that are not related to the REFURBISHMENT of the MEDICAL IMAGING EQUIPMENT.
4.5 Production and service provision
The REFURBISHER shall have documented procedures for REFURBISHMENT and service includingbut not limited to PROcEss validation，disinfection PROCESSES, identification，traceability andpackaging. In addition, the REFURBISHER shall make provisions to have the knowledge and theability for installing and servicing MEDICAL IMAGING EQUIPMENT,or to ensure that servicing canbe made available in those markets where the REFURBISHER makes refurbished MEDICALIMAGING EQUIPMENT available on the market.
