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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.50 Radiographic equipment>BS EN IEC 61223-3-7:2021 Evaluation and routine testing in medical imaging departments Acceptance and constancy tests. Imaging performance of X-ray equipment for dental cone beam computed tomography
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immediate downloadReleased: 2022-02-07
BS EN IEC 61223-3-7:2021 Evaluation and routine testing in medical imaging departments Acceptance and constancy tests. Imaging performance of X-ray equipment for dental cone beam computed tomography

BS EN IEC 61223-3-7:2021

Evaluation and routine testing in medical imaging departments Acceptance and constancy tests. Imaging performance of X-ray equipment for dental cone beam computed tomography

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Standard number:BS EN IEC 61223-3-7:2021
Pages:46
Released:2022-02-07
ISBN:978 0 539 03730 2
Status:Standard
BS EN IEC 61223-3-7:2021 - Evaluation and Routine Testing in Medical Imaging Departments

BS EN IEC 61223-3-7:2021 - Evaluation and Routine Testing in Medical Imaging Departments

Acceptance and Constancy Tests: Imaging Performance of X-ray Equipment for Dental Cone Beam Computed Tomography

Ensure the highest standards of imaging performance in your dental practice with the BS EN IEC 61223-3-7:2021 standard. This comprehensive document is essential for medical imaging departments, providing detailed guidelines for the evaluation and routine testing of X-ray equipment used in dental cone beam computed tomography (CBCT).

Key Features and Benefits

  • Standard Number: BS EN IEC 61223-3-7:2021
  • Pages: 46
  • Released: 2022-02-07
  • ISBN: 978 0 539 03730 2
  • Status: Standard

This standard is meticulously crafted to ensure that dental CBCT equipment meets stringent performance criteria, thereby guaranteeing high-quality imaging results. It is an indispensable resource for professionals who are committed to maintaining excellence in dental imaging.

Comprehensive Evaluation and Testing

The BS EN IEC 61223-3-7:2021 standard provides a thorough framework for both acceptance and constancy tests. These tests are crucial for verifying that new equipment meets the required specifications and for ensuring that existing equipment continues to perform optimally over time.

Acceptance Tests

Acceptance tests are conducted when new X-ray equipment is installed. These tests confirm that the equipment meets the manufacturer's specifications and complies with regulatory requirements. The standard outlines the specific procedures and criteria for these tests, ensuring that your equipment is ready for clinical use.

Constancy Tests

Constancy tests are performed regularly to monitor the ongoing performance of X-ray equipment. These tests help identify any deviations from the expected performance, allowing for timely maintenance and adjustments. The standard provides detailed guidelines for conducting these tests, ensuring that your equipment remains reliable and effective.

Why Choose BS EN IEC 61223-3-7:2021?

Adopting the BS EN IEC 61223-3-7:2021 standard offers numerous advantages for dental imaging departments:

  • Enhanced Image Quality: By adhering to the standard, you can ensure that your CBCT equipment produces high-quality images, which are crucial for accurate diagnosis and treatment planning.
  • Regulatory Compliance: The standard helps you meet regulatory requirements, reducing the risk of non-compliance and potential penalties.
  • Patient Safety: Regular testing and maintenance of X-ray equipment minimize the risk of equipment failure, enhancing patient safety.
  • Operational Efficiency: By maintaining optimal equipment performance, you can reduce downtime and improve the overall efficiency of your imaging department.

Detailed Content

The BS EN IEC 61223-3-7:2021 standard spans 46 pages and covers a wide range of topics related to the evaluation and testing of dental CBCT equipment. Key sections include:

  • Introduction: An overview of the standard's purpose and scope.
  • Definitions: Clear definitions of key terms and concepts used throughout the document.
  • Acceptance Testing Procedures: Detailed guidelines for conducting acceptance tests, including specific criteria and methods.
  • Constancy Testing Procedures: Comprehensive instructions for performing constancy tests, with a focus on maintaining equipment performance over time.
  • Performance Criteria: Specific performance criteria that X-ray equipment must meet to ensure high-quality imaging.
  • Documentation and Reporting: Guidelines for documenting test results and reporting findings, ensuring transparency and accountability.

Who Should Use This Standard?

The BS EN IEC 61223-3-7:2021 standard is designed for a wide range of professionals involved in dental imaging, including:

  • Radiologists: Ensure that imaging equipment meets the highest standards for diagnostic accuracy.
  • Medical Physicists: Conduct thorough evaluations and tests to maintain equipment performance.
  • Dental Practitioners: Utilize high-quality images for precise diagnosis and treatment planning.
  • Equipment Manufacturers: Verify that new equipment meets regulatory and performance standards.
  • Regulatory Authorities: Ensure compliance with industry standards and regulations.

Conclusion

Investing in the BS EN IEC 61223-3-7:2021 standard is a crucial step towards achieving excellence in dental imaging. By following the comprehensive guidelines for acceptance and constancy tests, you can ensure that your X-ray equipment delivers consistent, high-quality performance. This not only enhances diagnostic accuracy but also improves patient safety and operational efficiency.

Stay ahead in the field of dental imaging by adopting the BS EN IEC 61223-3-7:2021 standard and ensure that your practice meets the highest standards of imaging performance.

DESCRIPTION

BS EN IEC 61223-3-7:2021


This standard BS EN IEC 61223-3-7:2021 Evaluation and routine testing in medical imaging departments is classified in these ICS categories:
  • 11.040.50 Radiographic equipment
This part of IEC 61223 applies to DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT, hereafter also called DENTAL CBCT EQUIPMENT, that conforms to IEC 60601-2-63:2012 and IEC 60601-2-63:2012/AMD1:2017. NOTE 1 DENTAL CBCT EQUIPMENT is a subset of DENTAL EXTRA-ORAL X-RAY EQUIPMENT. NOTE 2 DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide one or more of PANORAMIC, CEPHALOMETRIC, tomosynthesis and DENTAL CBCT imaging modalities, all of which are in the scope of the IEC 60601-2-63 basic safety and performance standard. This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT. The aim of ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The requirements specified in this document are minimal requirements. The MANUFACTURER can establish criteria for the tests described here that exceed the levels contained in this document. CONSTANCY TESTS are performed to ensure that the functional performance of ME EQUIPMENT meets established criteria and to enable the early recognition of changes in the properties of components of the ME EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. This document also contains requirements for the ACCOMPANYING DOCUMENTS associated with ACCEPTANCE AND CONSTANCY TESTING of the DENTAL CBCT EQUIPMENT. This document does not apply to: - aspects of thermal, EMD (electromagnetic disturbances), mechanical and electrical safety; - aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and directly affect image quality, RADIATION OUTPUT and PATIENT positioning. NOTE 3 Such aspects are generally addressed by IEC 60601-1 (all parts). Equipment in the scope of IEC 61223-3-5 is excluded from the scope of this document. DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide modalities which are in the scope of IEC 61223-3-4. In this case, the respective clauses of the IEC 61223-3-4 apply. The object of this document is to establish: - the essential parameters which describe the performance of DENTAL CBCT EQUIPMENT with regard to the image quality, RADIATION OUTPUT and PATIENT positioning; - methods of testing and whether measured quantities related to those parameters comply with the specified requirements. These methods rely on non-invasive measurements performed once the installation or a MAJOR SERVICE ACTION is completed.