IEC 63077 pdf free download
IEC 63077 pdf free download.Good refurbishment practices for medical imaging equipment.
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.
4.8 Document control
The REFURBISHER shall control all work instructions and procedures used to refurbish MEDICAL IMAGING EQUIPMENT.
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 MANUFACTURER 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.
4.10 Control of design and design changes
The REFURBISHER shall review, verify, and validate potential design changes to ensure that the safety and performance requirements of the MEDICAL IMAGING EQUIPMENT are not changed from its original or applicable valid registration. All changes, including parts, shall be evaluated to determine if the MEDICAL IMAGING EQUIPMENT needs new certification and the REFURBISHER needs registration, as it may become the legal MANUFACTURER.
NOTE Control of design and design changes are not applicable to a REFURBISHER because this can result in the need of a new certification of the MEDICAL IMAGING EQUIPMENT and a legal MANUFACTURER status of the
REFURBISHER.
4.11 RISK management PROCESS
The REFURBISHER shall also establish a RISK management PROCESS that includes any RISK introduced by the REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT. This includes changes that would affect parts.
5 Specific requirements for good REFURBISHMENT practice
5.1 General
The REFURBISHER shall establish a specific PROCESS for the REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT that, in addition to the general requirements described in Clause 4, includes the following specific requirements.
5.2 Selection of MEDICAL IMAGING EQUIPMENT for REFURBISHMENT
The REFURBISHER shall determine the criteria that USED MEDICAL IMAGING EQUIPMENT needs to meet in order to qualify for REFURBISHMENT, based on an assessment of the RISK in accordance with Iso 14971:2007 associated with REFURBISHMENT, for any type of MEDICAL IMAGING 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 be restored to at least the original safety and performance levels, including all mandatory safety updates, shall not be refurbished.IEC 63077 pdf download.
