[New aspects from legislation, guidelines and safety standards for MRI]

Area of Science:

• Medical Imaging Physics
• Biomedical Engineering
• Radiological Safety Standards

Context:

• Magnetic Resonance (MR) scanner operation relies on standards and guidelines, not direct laws.
• The International Electrotechnical Commission (IEC) 60601-2-33 standard governs MR scanner operating instructions.
• Recent approvals allow static magnetic fields up to 8 Tesla (T) for clinical MR imaging (first level controlled mode).

Purpose:

• To outline the evolving regulatory landscape for Magnetic Resonance (MR) imaging, including ultra-high field scanners.
• To detail the implications of the IEC 60601-2-33 standard update, including the new Fixed Parameter Option (FPO).
• To address the current lack of general regulation for pregnant workers in MR environments and contrast agent use in breastfeeding women.

Summary:

• The IEC 60601-2-33 standard now permits 8 T MR scanners in clinical use and introduces the Fixed Parameter Option (FPO) for simplified patient testing with implants.
• Ultra-high field scanners (7-8 T) await CE certification in Europe, with existing installations retaining experimental status.
• Regulations for pregnant workers in MR environments remain unresolved, with differing guidelines in parts of Europe regarding exposure limits.

Impact:

• The updated IEC standard facilitates the clinical adoption of advanced MR technologies, such as 8 T scanners.
• The FPO aims to streamline safety protocols for patients with medical implants undergoing MR examinations.
• Clarification on safety guidelines for pregnant workers and contrast agent use is crucial for healthcare professionals and patient safety.