BS EN IEC 63077:2019 pdf free download – Good refurbishment practices for medical imaging equipment
1 Scope
This document describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR , REWORK , software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGING EQUIPMENT ’s performance, safety specifications, or INTENDED USE according to its original or applicable valid registration.
3.1 1 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. R EFURBISHMENT 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.
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 ; and
– an environment for REFURBISHMENT that is in compliance with the applicable environmental,occupational health and safety requirements.
4.5 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.