BS EN IEC 63077:2019 pdf 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.
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.
4.6 Control of nonconforming PRODUCT
The REFURBISHER shall ensure that a PRODUCT， that does not conform to PRODUCT requirements, is identified during REFURBISHMENT and controlled to prevent its unintended use or delivery. When a nonconforming PRODUCT is corrected during REFURBISHMENT, it shall be subject to re-verification to demonstrate conformity to the requirements of the original MANUFACTURER.
4.7 Post-market surveillance PROCESS
The REFURBISHER shall collect feedback from customers and establish documented procedures to notify regulatory authorities of adverse events caused by the refurbished MEDICAL IMAGING EQUIPMENT. The PROCESS shall also determine if the adverse event is related to the REFURBISHMENT of the USED MEDICAL IMAGING EQUIPMENT or needs to be reported to the original MANUFACTURER.
The REFURBISHER shall also establish its own post-market surveillance PROCESS to monitor whether the additional RISKS resulting from REFURBISHMENT have been adequately mitigated.The REFURBISHER shall enable monitoring of its installed base of refurbished MEDICAL IMAGING EQUIPMENT to allow for update management for safety and performance.
NOTE To term installed base: All refurbished MEDICAL IMAGING EQUIPMENT provided by the REFURBISHER and installed, which meets all acceptance criteria for verification of installation.
4.9 Purchasing
The REFURBISHER shall document procedures to ensure that purchased components, service parts and other materials such as packaging material, services as needed for REFURBISHMENT conforms to purchasing information as specified by the MANUF ACTURER of the MEDICAL IMAGING EQUIPMENT. The REFURBISHER shall establish dedicated supplier management capabilities when components, services, or other materials such as packaging materials, services are purchased.BS EN IEC 63077 pdf download.