BS EN IEC 63077:2019 pdf free.Good refurbishment practices for medical imaging equipment.
REFURBISHMENT PROCESS or combination of PROCESSES applied during the EXPECTED SERVICE LIFE to restore  USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance according to the specification of the MANUFACTURER. Note 1 to entry: REFURBISHMENT can include activities such as REPAIR, REWORK, replacement of worn parts, and update of software/hardware but does not include activities that result in the need of a new certification of the MEDICAL IMAGING EQUIPMENT and a legal MANUFACTURER status of the REFURBISHER. Note 2 to entry: . REFURBISHMENT does not include restoration after the EXPECTED SERVICE LIFE. Note 3 to entry: In some jurisdictions a definition of the term remanufacturer is available. REFURBISHMENT differs from actions related to REFURBISHER acting in the role of a remanufacturer. Note 4 to entry: In some jurisdictions a definition of the term reprocessing is available. In those jurisdictions the term reprocessing is typically related to reusable medical devices such as single-use medical devices and is related to processes such as sterilization. REFURBISHMENT is different from reprocessing. Note 5 to entry: REFURBISHMENT may result in a higher level of safety because e.g. safety updates released by the MANUFACTURER for the relevant MEDICAL IMAGING EQUIPMENT are applied within REFURBISHMENT.The REFURBISHER shall have in place a system for managing complaints. In addition, the REFURBISHER shall communicate to the original MANUFACTURER all customer complaints that are not related to the REFURBISHMENT of the MEDICAL IMAGING EQUIPMENT. Production and service provision The REFURBISHER shall have documented procedures for REFURBISHMENT and service including but not limited to PROCESS validation, disinfection PROCESSES, identification, traceability and packaging. In addition, the REFURBISHER shall make provisions to have the knowledge and the ability for installing and servicing MEDICAL IMAGING EQUIPMENT, or to ensure that servicing can be made available in those markets where the REFURBISHER makes refurbished MEDICAL IMAGING EQUIPMENT available on the market.BS EN IEC 63077 pdf download.