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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.50 Radiographic equipment>BS EN IEC 61223-3-6:2020 Evaluation and routine testing in medical imaging departments Acceptance and constancy tests. Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation
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BS EN IEC 61223-3-6:2020 Evaluation and routine testing in medical imaging departments Acceptance and constancy tests. Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation

BS EN IEC 61223-3-6:2020

Evaluation and routine testing in medical imaging departments Acceptance and constancy tests. Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation

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Standard number:BS EN IEC 61223-3-6:2020
Pages:60
Released:2020-04-06
ISBN:978 0 580 98932 2
Status:Standard
BS EN IEC 61223-3-6:2020 - Evaluation and Routine Testing in Medical Imaging Departments

BS EN IEC 61223-3-6:2020

Evaluation and Routine Testing in Medical Imaging Departments

Acceptance and Constancy Tests: Imaging Performance of Mammographic X-ray Equipment in Tomosynthesis Mode

The BS EN IEC 61223-3-6:2020 standard is an essential document for professionals in the field of medical imaging, particularly those working with mammographic X-ray equipment in tomosynthesis mode. Released on April 6, 2020, this comprehensive standard provides detailed guidelines and procedures for the evaluation and routine testing of imaging performance, ensuring that equipment meets the necessary acceptance and constancy criteria.

With a total of 60 pages, this standard is a critical resource for maintaining the highest quality of imaging performance in medical imaging departments. It is designed to assist healthcare professionals, technicians, and engineers in conducting thorough and effective tests that are crucial for patient safety and diagnostic accuracy.

Key Features and Benefits

  • Comprehensive Guidelines: The standard offers a complete set of guidelines for evaluating and testing mammographic X-ray equipment, ensuring that all aspects of imaging performance are covered.
  • Focus on Tomosynthesis: Special emphasis is placed on the tomosynthesis mode of operation, which is increasingly used in modern mammography for its ability to provide detailed 3D images.
  • Ensures Compliance: Adhering to this standard helps medical imaging departments comply with international regulations and standards, promoting consistency and reliability in imaging results.
  • Enhances Diagnostic Accuracy: By following the acceptance and constancy tests outlined in the standard, healthcare providers can enhance the diagnostic accuracy of mammographic examinations, leading to better patient outcomes.
  • Supports Quality Assurance: Routine testing as per the standard supports ongoing quality assurance efforts, helping to identify and rectify any issues with imaging equipment promptly.

Who Should Use This Standard?

This standard is indispensable for a wide range of professionals in the medical imaging field, including:

  • Radiologists: To ensure the imaging equipment they use meets the highest standards of performance and safety.
  • Medical Physicists: For conducting precise and accurate tests that are critical for equipment calibration and maintenance.
  • Biomedical Engineers: To assist in the design, testing, and maintenance of mammographic X-ray equipment.
  • Quality Assurance Managers: To implement and oversee quality control processes within medical imaging departments.

Technical Specifications

The BS EN IEC 61223-3-6:2020 standard is identified by the following technical specifications:

  • Standard Number: BS EN IEC 61223-3-6:2020
  • Pages: 60
  • Release Date: April 6, 2020
  • ISBN: 978 0 580 98932 2
  • Status: Standard

Importance of Mammographic Tomosynthesis

Mammographic tomosynthesis is a revolutionary advancement in breast imaging technology. Unlike traditional 2D mammography, tomosynthesis provides a three-dimensional view of the breast, allowing for more accurate detection and diagnosis of breast cancer. This mode of operation reduces the overlap of tissues, which can obscure lesions in standard mammograms, thus improving the clarity and detail of the images.

The BS EN IEC 61223-3-6:2020 standard is specifically tailored to address the unique challenges and requirements of testing mammographic X-ray equipment in tomosynthesis mode. By following the guidelines set forth in this standard, medical imaging departments can ensure that their equipment is capable of delivering the high-quality images necessary for effective breast cancer screening and diagnosis.

Conclusion

In the ever-evolving field of medical imaging, staying up-to-date with the latest standards and practices is crucial. The BS EN IEC 61223-3-6:2020 standard provides a robust framework for evaluating and testing mammographic X-ray equipment, particularly in the advanced tomosynthesis mode. By implementing the acceptance and constancy tests outlined in this standard, medical imaging departments can ensure the highest levels of performance, safety, and diagnostic accuracy, ultimately leading to improved patient care and outcomes.

Whether you are a radiologist, medical physicist, biomedical engineer, or quality assurance manager, this standard is an invaluable resource for maintaining excellence in mammographic imaging. Embrace the guidelines of BS EN IEC 61223-3-6:2020 and take a proactive approach to quality assurance in your medical imaging department.

DESCRIPTION

BS EN IEC 61223-3-6:2020


This standard BS EN IEC 61223-3-6:2020 Evaluation and routine testing in medical imaging departments is classified in these ICS categories:
  • 11.040.50 Radiographic equipment
IEC 61223-3-6:2020 applies to the performance of MAMMOGRAPHIC X-RAY EQUIPMENT when used in MAMMOGRAPHIC TOMOSYNTHESIS modes of operation, with respect to image quality and dose. Excluded from the scope of this document are: - MAMMOGRAPHIC X-RAY EQUIPMENT modes of operation other than MAMMOGRAPHIC TOMOSYNTHESIS; - 2D images synthesised from the tomosynthesis images; - reconstructive TOMOGRAPHY other than MAMMOGRAPHIC TOMOSYNTHESIS; - CT SCANNERS covered by IEC 61223-3-5. IEC 61223-3-6:2020 defines a) the essential parameters which describe the acceptability criteria of MAMMOGRAPHIC TOMOSYNTHESIS modes of operation of MAMMOGRAPHIC X-RAY EQUIPMENT with regard to image quality and dose, b) the methods of testing whether measured quantities related to those parameters comply with specified tolerances, and c) CONSTANCY TEST frequency when required. This document is intended to be applied along with the acceptability criteria included in IEC 61223-3-2 or equivalent protocol for 2D mammography which are also relevant for MAMMOGRAPHIC TOMOSYNTHESIS modes of operation. These methods mainly rely on non-invasive measurements that use appropriate test equipment and are performed during or after the installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST. Tests required by a higher level of compliance take precedence over similar tests with a lower level of compliance. When the results of the ACCEPTANCE TEST are in compliance with the expected values, the BASELINE VALUES for the subsequent CONSTANCY TESTS are established.