There is a specific standard for radiotherapy treatment planning systems, IEC 62083 Edition 2.0 (2009-09-23) Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems. When there is a specific standard, it takes precedent over general standards.

IEC 60601-1 only applies to medical electrical equipment. So software that is a stand alone product does not fall within the scope of IEC 60601-1.A new work item on Healthcare Software Systems was recently approved. This new standard is intended to apply to stand alone software and will have similar (but not necessarily the same) requirements as the PEMS section of 60601-1. Work is just beginning on this new standard, the tentative schedule is for it to be published in 2014. We will be providing regular updates on the progress of this new standard as part of our SoftwareCPR Standards Navigator subscription.