BS EN IEC 63077:2019 - Good Refurbishment Practices for Medical Imaging Equipment

In the ever-evolving world of medical technology, ensuring the highest standards of quality and safety is paramount. The BS EN IEC 63077:2019 standard, titled "Good Refurbishment Practices for Medical Imaging Equipment," is an essential guide for professionals in the medical imaging industry. Released on January 3, 2020, this standard provides comprehensive guidelines to ensure that refurbished medical imaging equipment meets the necessary safety and performance criteria.

Overview of the Standard

The BS EN IEC 63077:2019 standard is a crucial document for anyone involved in the refurbishment of medical imaging equipment. With a total of 20 pages, it offers detailed instructions and best practices to ensure that refurbished equipment is safe, reliable, and effective. The standard is recognized internationally and is a testament to the commitment to quality and safety in the medical imaging field.

Key Features

• Standard Number: BS EN IEC 63077:2019
• Pages: 20
• Release Date: January 3, 2020
• ISBN: 978 0 580 99848 5
• Status: Standard

Importance of Good Refurbishment Practices

Refurbishment of medical imaging equipment is a cost-effective way to extend the life of valuable medical devices. However, it is crucial that these refurbished devices meet the same standards as new equipment to ensure patient safety and diagnostic accuracy. The BS EN IEC 63077:2019 standard provides a framework for achieving this goal, outlining the necessary steps and considerations for refurbishing medical imaging equipment.

Benefits of Adhering to the Standard

By following the guidelines set forth in the BS EN IEC 63077:2019 standard, organizations can benefit in several ways:

• Enhanced Safety: Ensures that refurbished equipment meets stringent safety standards, reducing the risk of malfunctions or accidents.
• Improved Performance: Guarantees that refurbished devices perform at optimal levels, providing accurate and reliable diagnostic results.
• Cost Efficiency: Extends the lifespan of existing equipment, offering a cost-effective alternative to purchasing new devices.
• Environmental Impact: Promotes sustainability by reducing electronic waste and conserving resources through the reuse of existing equipment.

Who Should Use This Standard?

The BS EN IEC 63077:2019 standard is designed for a wide range of professionals in the medical imaging industry, including:

• Refurbishment Companies: Organizations that specialize in refurbishing medical imaging equipment can use this standard to ensure their processes meet industry standards.
• Healthcare Facilities: Hospitals and clinics that utilize refurbished equipment can rely on this standard to verify the quality and safety of their devices.
• Regulatory Bodies: Agencies responsible for overseeing medical device safety can use this standard as a benchmark for evaluating refurbished equipment.
• Manufacturers: Original equipment manufacturers (OEMs) can reference this standard to ensure their refurbishment practices align with industry expectations.

Conclusion

The BS EN IEC 63077:2019 standard is an invaluable resource for anyone involved in the refurbishment of medical imaging equipment. By adhering to the guidelines outlined in this standard, organizations can ensure that their refurbished devices meet the highest standards of safety and performance. This not only protects patients and healthcare providers but also contributes to the overall efficiency and sustainability of the medical imaging industry.

With its comprehensive approach and international recognition, the BS EN IEC 63077:2019 standard is a must-have for any organization committed to excellence in the refurbishment of medical imaging equipment. Embrace the best practices outlined in this standard and take a significant step towards ensuring the quality and reliability of your refurbished medical devices.

BS EN IEC 63077:2019

This standard BS EN IEC 63077:2019 Good refurbishment practices for medical imaging equipment is classified in these ICS categories:

• 11.040.55 Diagnostic equipment

IEC 63077:2019 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. This document 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 this document 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 WHOLEBODY 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 TOMOGRAPHS (PET);
– PET/CT hybrid systems combining a POSITRON EMISSION TOMOGRAPH with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT);
– PET/MRI hybrid systems combining a POSITRON EMISSION TOMOGRAPH with MAGNETIC RESONANCE EQUIPMENT: and
– other combinations of the MEDICAL IMAGING EQUIPMENT or systems listed above.
This document does not apply to endoscopic equipment, funduscopic equipment, radiation therapy equipment, nor associated systems.
IEC 63077:2019 includes the following significant technical changes with respect to IEC PAS 63077:2016:
a) the scope was delineated more clearly;
b) an informative cross reference list of IEC 63077 vs ISO 13485 (Annex A) was added;
c) smaller corrections were performed.