To ensure high quality and safety and effectiveness, our ecoline systems undergo our 5-step Quality Process and receive the Proven Excellence Quality Certificate after being successfully refurbished. With that Siemens Healthineers confirms that ecoline systems are refurbished following independently certified processes according to the relevant standard for medical devices (ISO 134851). This takes place in alignment with the procedures of the global refurbishment standard for medical imaging equipment², where applicable, leading to a quality level comparable to when new.
According to our Proven Excellence Quality Certificate
ISO 13485: 2016 Medical devices – Quality management systems – Requirements for regulatory purposes
IEC 63077: 2019 Good refurbishment practices for medical imaging equipment