The international standard, IEC 63077, is the product of more than a decade of work by DITTA members to ensure that refurbished medical imaging equipment -- from x-ray to MRI scanners -- meets the intended use, performance, and safety specifications of the original equipment manufacturer, the association noted.
IEC 63077 now allows manufacturers to receive certification after meeting an international refurbishment standard. The document also gives regulators, authorities, and healthcare providers a clear way to measure the quality and safety of refurbished medical imaging equipment. This may lead certain countries to reconsider restricting the import and distribution of refurbished equipment based on the extent to which the equipment meets quality and safety standards, DITTA said.
DITTA believes that use of IEC 63077 and similar international standards can help increase global revenue generated from refurbished medical imaging equipment, improve patients' access to more affordable healthcare, and reduce waste generation and save energy, resources, and materials.
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