IEC standards for radiological equipment: issues for the industry and for end users

Area of Science:

• Medical Imaging Technology
• Standards Development
• Electrotechnical Engineering

Background:

• The International Electrotechnical Commission (IEC) is a global standards organization founded in 1906.
• IEC Technical Committee (TC) 62 manages medical equipment standards, with Subcommittee (SC) 62B focusing on medical imaging equipment.
• A 2005 meeting of IEC SC 62B's Steering Group was convened to address X-ray standards.

Purpose of the Study:

• To review existing X-ray standards within IEC SC 62B.
• To establish a strategic approach for developing new standards in medical imaging equipment.
• To consolidate the agenda for future standards development, prioritizing whole systems.

Main Methods:

• A special meeting of the IEC SC 62B Steering Group was held in September 2005.
• Discussions focused on reviewing current X-ray standards and identifying needs for new ones.
• Liaisons with relevant organizations were reviewed and established.

Main Results:

• The agenda for new X-ray standards was definitively established and consolidated.
• The focus for new standards was set on whole systems.
• Liaisons with SENTINEL, the International Atomic Energy Agency, and the International Commission on Radiological Protection were addressed.

Conclusions:

• The 2005 meeting successfully outlined a path for developing new IEC standards for X-ray and medical imaging equipment.
• The strategy emphasizes a systems-level approach to standardization.
• Future work will include revisiting acceptance testing and quality assurance standards.