BS EN IEC 63077:2019

What is BS EN IEC 63077 - Refurbishment for imaging equipment about?  

BS EN IEC 63077 discusses good refurbishment practices for medical imaging equipment. BS EN IEC 63077 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. 

BS EN IEC 63077 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. 

The medical imaging equipment and systems covered by BS EN IEC 63077 include: 

• X-ray equipment 
• X-ray equipment for radioscopically guided interventional procedures 
• X-ray equipment for computed tomography 
• Magnetic resonance equipment 
• Ultrasonic diagnostic equipment 
• Gamma cameras 
• Planar whole-body imaging equipment 
• Equipment for single-photon emission computed tomography (SPECT) 
• SPECT/CT hybrid systems, combining a gamma camera with x-ray equipment for computed tomography (CT) 
• Positron emission tomography (pet) 
• PET/CT hybrid systems combining a positron emission tomography with x-ray equipment for computed tomography (CT) 
• PET/MRI hybrid systems combining a positron emission tomography with magnetic resonance equipment 
• Other combinations of the medical imaging equipment or systems listed above 

Who is BS EN IEC 63077 - Good refurbishment practices for imaging equipment for? 

BS EN IEC 63077 on good refurbishment practices for imaging equipment is useful for: 

• Medical imaging equipment manufacturers 
• Suppliers of medical imaging equipment 
• Test centres for medical imaging equipment 

Why should you use BS EN IEC 63077 - Refurbishment for imaging equipment? 

Refurbishment is a systematic process for bringing used medical imaging equipment to the same condition as when new or even better for medical imaging equipment. 

BS EN IEC 63077 best practice guideline helps you with requirements on the quality management system, corrective actions, preventive action quality management system, production provision, service provision customer complaints, control of the non-conforming product, post-market surveillance process, document control, purchasing, control of design, and design changes for the refurbishment of used medical imaging equipment. 

BS EN IEC 63077 also provides good refurbishment practices on the selection of medical imaging equipment for refurbishment, evaluating market access requirements, preparation for refurbishment, disassembly, packing, transport, planning, installation of software and hardware, performance test, safety test, and refurbishment labels for used medical imaging equipment.  

This helps in improving performance and ensures the safety of the medical imaging equipment. In addition, minimizes hazardous situations that may occur while operating medical imaging equipment. 

What’s changed since the last update? 

BS EN IEC 63077:2019 supersedes IEC PAS 63077:2016, which has been withdrawn. BS EN IEC 63077:2019 has some technical changes with respect to IEC PAS 63077:2016. These includes: 

• The scope was delineated more clearly 
• An informative cross reference list of IEC 63077 vs iso 13485 (annex a) was added 
• Smaller corrections were performed