What is BS EN IEC 62464‑1- Determination of essential image quality parameters about?
BS EN IEC 62464 is a standard that discusses magnetic resonance equipment for medical imaging. BS EN IEC 62464‑1 provides the best industry guidance on the determination of essential image quality parameters to ensure high-quality magnetic resonance equipment.
BS EN IEC 62464‑1 is the first part of a multi-part series that specifies measurement procedures for the determination of many essential image quality parameters for magnetic resonance equipment. Measurement procedures as addressed under BS EN IEC 62464‑1 are suitable for quality assessment in the acceptance test, and quality assurance in the constancy test.
BS EN IEC 62464‑1 presents requirements for constancy tests suitable for magnetic resonance equipment quality assurance programs concerning essential image quality parameters. It emphasizes on consistently repeatable, automated measuring tools that facilitate trend analysis and the frequent quick testing of a small set of important parameters that are sensitive to the overall operating characteristics of the magnetic resonance equipment.
Note1: None of the methods found under BS EN IEC 62464‑1 have been extensively tested at a static magnetic field intensity above 3 T. Initial tests indicate the methods function correctly when appropriate TEST DEVICE fillers are used.
Note2: BS EN IEC 62464‑1 does not address
- Image quality assessment of MR EQUIPMENT with a static magnetic field intensity greater than 8 Tesla, if not otherwise stated
- Image quality affected by MR-compatibility issues
- Special diagnostic procedures such as flow imaging, perfusion, diffusion, radiotherapy, and image-guided therapy applications
- Type test
Note 3: The scope of BS EN IEC 62464‑1 is also limited to measuring image quality characteristics in images acquired on TEST DEVICES, not in PATIENT images.
Who is BS EN IEC 62464‑1- Determination of essential image quality parameters for?
BS EN IEC 62464‑1 on the determination of essential image quality parameters is relevant to:
- Magnetic resonance equipment manufacturers
- Test laboratory that confirms the performance of magnetic resonance equipment
- Medical regulatory authorities
- Medical organizations who want to perform ACCEPTANCE and CONSTANCY TESTS
Why should you use BS EN IEC 62464‑1- Determination of essential image quality parameters?
Several standards on quality assurance and quality control have been developed to address the need for quantitative assessment of system performance and system maintenance. Having a standardized set of test methods minimizes the amount of work for the MR manufacturers to demonstrate the performance characteristics of the MR scanners for many different countries and, in addition, these countries do not have to formulate their requirements for the performance testing.
BS EN IEC 62464‑1 assist in meeting minimum requirements and general safety guidelines on magnetic resonance and selecting the best method as the preferred method where good alternatives are available and are therefore also acceptable.
With compliance and obedience to BS EN IEC 62464‑1, you can ensure the efficacy of the MR equipment and produce a standardized product.
What’s changed since the last update?
BS EN IEC 62464‑1:2019 supersedes IEC 62464‑1:2007, which is withdrawn. BS EN IEC 62464‑1:2019 has made some technical changes compared to IEC 62464‑1:2007. These include:
- The tests have been revised to comply with the technical progress
- The range of B0 was increased from 4 T to 8 T