BS EN IEC 63077:2019 pdf free.Good refurbishment practices for medical imaging equipment.
4.6Control of nonconforming PRoDUCT
The REFURBISHER shall ensure that a PRODuCT,that does not conform to PRODUCTrequirements, is identified during REFURBISHMENT and controlled to prevent its unintended useor delivery. When a nonconforming PRoDucT is corrected during REFURBISHMENT,it shall besubject to re-verification to demonstrate conformity to the requirements of the originalMANUFACTURER.
4.7Post-market surveillance PROCEss
The REFURBISHER shall collect feedback from customers and establish documentedprocedures to notify regulatory authorities of adverse events caused by the refurbishedMEDICAL IMAGING EQUIPMENT.The PRocEss shall also determine if the adverse event is relatedto the REFURBISHMENT of the uSED MEDICAL IMAGING EQUIPMENT or needs to be reported to theoriginal MANUFACTURER.
The REFURBISHER shall also establish its own post-market surveillance PRoCESs to monitorwhether the additional RIsKs resulting from REFURBISHMENT have been adequately mitigated.
The REFURBISHER shall enable monitoring of its installed base of refurbished MEDICAL IMAGINGEQUIPMENT to allow for update management for safety and performance.
NOTE To term installed base: All refurbished MEDICAL IMAGING EQUIPMENT provided by the REFURBISHER andinstalled, which meets all acceptance criteria for verification of installation.
4.8Document control
The REFURBISHER shall control all work instructions and procedures used to refurbish MEDICALIMAGING EQUIPMENT.
4.9Purchasing
The REFURBISHER shall document procedures to ensure that purchased components, serviceparts and other materials such as packaging material, services as needed for REFURBISHMENTconforms to purchasing information as specified by the MANUFACTURER of the MEDICAL IMAGINGEQUIPMENT. The REFURBISHER shall establish dedicated supplier management capabilitieswhen components，services,or other materials such as packaging materials，services arepurchased.
4.10Control of design and design changes
The REFURBISHER shall review, verify, and validate potential design changes to ensure that thesafety and performance requirements of the MEDICALIMAGING EQUIPMENT are not changed fromits original or applicable valid registration.All changes,including parts,shall be evaluated todetermine if the MEDICAL IMAGING EQUIPMENT needs new certification and the REFURBISHERneeds registration, as it may become the legal MANUFACTURER.
5 Specific requirements for good REFURBISHMENT practice
5.1General
The REFURBISHER shall establish a specific PRocESs for the REFURBISHMENT of uSED MEDICALIMAGING EQUIPMENT that,in addition to the general requirements described in Clause 4,includes the following specific requirements.
5.2Selection of MEDICAL IMAGING EQUIPMENT for REFURBISHMENT
The REFURBISHER shall determine the criteria that uSED MEDICAL IMAGING EQUIPMENT needs tomeet in order to qualify for REFURBISHMENT，based on an assessment of the RISK inaccordance with lSo 14971:2007 associated with REFURBISHMENT，for any type of MEDICALIMAGING EQUIPMENT it wishes to PROCESs.
This determination shall consider the following items:
a) INTENDED uSE and NORMAL USE of the MEDICAL IMAGING EQUIPMENT;b)EXPECTED SERVICE LIFE;
c)applicable standards;
d) service/maintenance history for the MEDICAL IMAGING EQUIPMENT;
e) existing procedures for the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT,such as service, REPAIR,production, and maintenance.
USED MEDICAL IMAGING EQUIPMENT that is at the end of EXPECTED SERVICE LIFE or that cannot berestored to at least the original safety and performance levels,including all mandatory safetyupdates,shall not be refurbished.
5.3Evaluating market access requirements
To ensure regulatory compliance, the REFURBISHER shall have a PRocEss in place to evaluatemarket access requirements，such as valid registrations and licenses or restrictions,and toprovide instructions for use in the appropriate languages,safety information，warnings, andlabels.
Only a MANUFACTURER can register a MEDICAL IMAGING EQUIPMENT.
Refurbished MEDICAL IMAGING EQUIPMENT for which the registrations or licenses of the originalor refurbished MEDICALIMAGING EQUIPMENT has been discontinued or where there is no licensemay require a registration or license prior to commercialization of the refurbished MEDICALIMAGING EQUIPMENT.BS EN IEC 63077 pdf download.