International Electrotechnical Commission (IEC) standards cover safety and performance aspects of medical equipment used in radiation therapy and diagnostic imaging along with acceptance and constancy testing requirements. Standards are updated on a regular basis and changes to the standards directly impact the design as well as performance and testing requirements for radiation oncology, nuclear medicine, and diagnostic imaging equipment. This session will review recent changes to IEC standards covering those areas (and the impact on required testing/evaluation criteria). In addition, this session will cover the current status of the FDAâ€™s transition to allow manufacturers to use conformance to IEC standards in lieu of the ERCP performance criteria for some medical imaging equipment. This change will have a direct impact on diagnostic physicists as some IEC standards have different performance criteria or testing methodologies than are described in 21 CFR. The scope of the proposed changes and the process being developed by the FDA, MITA, AAPM and CRCPD to minimize the confusion and impact on compliance testing will be presented. Finally, the open work items and forthcoming changes from IEC standards will be reviewed and opportunities for medical physicists to get involved in the development and review of proposed constancy and acceptance testing standards will be presented.
1. Understand and become familiar with the recent updates to IEC standards on equipment for radiotherapy, nuclear medicine, radiation dosimetry, and diagnostic imaging equipment
2. Understand how the planned FDA transition to allow conformance to IEC standards in lieu of some EPRC performance standards for diagnostic imaging equipment will impact the clinical practice of medical physics
3. Learn how to contribute to the development of IEC standards and US comments and votes on standards in preparation.
Not Applicable / None Entered.