An Introduction to Standards for MRI Safety
Abstract
Documentary standards play an important role in disseminating a consensus perspective on appropriate test methodologies, on seeking uniformity in labeling practices, and appropriate MRI system output constraints to ensure a high level of safety in MRI. The standards introduced in this article are considered central, but not the exclusive standards, for safety and are routinely cited by all MRI vendors or those implant vendors seeking MR Conditional labeling. The key MR safety standard (IEC 60601-2-33) defines expectations for controlling the outputs of an MRI scanner, relevant information of importance to users of the systems and implant vendors seeking MR Conditional labeling. The National Electrical Manufacturers Association/Medical Imaging and Technology Alliance (NEMA/MITA) standards related to safety (MS-4, -8, -10, -14) define measurement methods that support IEC 60601-2-33. The subset of relevant ASTM standards covered in this article (F2119, F2182, and F2503) relate to image artifacts, radio frequency (RF)-induced heating, and the universal labeling standard. The key horizontal ‘standard’ for active implants, also used by some passive implant vendors, is ISO TS10974. Additionally, the organizations and processes that produce, maintain, use, and promulgate standards are also discussed. Lastly, the concept of ‘safety’ is also explored, as defined by standards, and how device vendor submissions to regulators justify the safety of devices to be appropriate.