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IEC 60601-2-33 Magnetic Resonance Equipment for Medical Diagnosis Testing

Medical electrical equipment – Part 2-33: the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

IEC 60601-2-33 Introduction:

IEC 60601 2 33 and EN 60601 2 33 testing is written at a moment in which the technical evolution of MR equipment is in rapid progress and the scientific foundation of its safe use is still expanding.

IEC 60601-2-33 testing addresses technical aspects of the medical diagnostic MR system and the MR equipment therein related to the safety of patients examined with this system, the safety of the MR worker involved with its operation and the safety of the MR worker involved with the development, manufacturing, installation, and servicing of the MR system. Where limits of electromagnetic fields (EMF) exposure of patients and MR workers are stated, these limits do not imply that such levels of exposure can be assumed to be acceptable for workers in other professional settings and for the population at large. The limits provide a sensible balance between risks for the patients and MR workers and benefits for the patients.

Organizational aspects of safety are the task of the responsible organization. This task includes adequate training of staff, rules of access to the MR system, qualification of staff for decisions that are related to safety, definition of medical responsibility and specific requirements for personnel following from that responsibility when the patient is in or near the MR system.

Examples of such organizational aspects are:

  • Operation in first level controlled operating mode;
  • Emergency procedures for resuscitation of the patient who is in the MR system;
  • Emergency procedures after a quench of the superconductive magnet when present;
  • Set-up and maintenance of a protocol for screening the patient for contraindications or for conditions that may affect acceptable exposure;
  • Rules for ROUTINE monitoring and for medical supervision of the patient during the exam.
  • Rules to minimize and to limit the exposure of MR workers to EMF.

The introduced EMF exposure limits required in this standard for an MR worker will never exceed those allowed for patients. All exposure limits allowed for a patient and for an MR worker are expected to protect them against negative health effects and unacceptable risks. For the exposure to static magnetic fields, subjective short-term physiological and sensory effects are expected. These influence the wellbeing of the MR worker marginally and only during or shortly after exposure.

For the exposure to gradient output and RF transmit fields, normally no short-term physiological and sensory effects are expected for MR workers.

In addition no experimental or theoretical basis for cumulative biological effects in humans, resulting from exposure at the allowed levels has been generally accepted. The requirements for acoustic noise exposure are different for patients and MR workers.

Keystone Compliance assists manufacturers with IEC 60601-2-33 and EN 60601-2-33 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-33 test lab needs.