Milan, Italy, was the stage of two important IECEE events last April, both hosted by
IMQ SpA, the IECEE’s Italian member body. The first one, on 14-15 April 2009, involved the IECEE Medical Electrical Equipment Task Force, and consisted of both a meeting and a workshop. The second event was a workshop on software evaluation which took place on 16-17 April.
Medical electrical equipment
A CAT scan, CT scan, or computerized axial tomography is a way of x-raying a mass in the body that provides three-dimensional views of the mass
IECEE set up the IECEE Medical Electrical Equipment (MEE) Task Force in September 2007 to consider the implementation of risk management requirements in the third edition of
IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The Task Force consists of 20 members who represent various interests in the field of medical electrical equipment (industry, government agencies, certification bodies, IEC Technical Committee). The group, for which the convenor is Alfred Dolan of the University of Toronto, Canada, is responsible for:
- developing guidelines and working instructions on how to implement the relevant clauses of IEC 60601-1 in helping manufacturers demonstrate compliance with “risk management process” as set down in ISO 14971, Medical devices - Application of risk management to medical devices
- developing a checklist aimed at assisting the medical equipment industry, official authorities and stakeholders around the world in testing in the appropriate manner
- acting as an Advisory Group on the common understanding of ISO 14971 with respect to IEC 60601-1
organizing specific training sessions dealing with risk management issues.
The April meeting of the MEE Task Force was the fifth since its inception in 2007. Throughout these gatherings, the group has developed guidance and finalized Test Report Forms related to risk management. They also organized the introductory training session that took place immediately after the meeting.
About 70 representatives from CBTLs (Certification Body Testing Laboratories) attended the workshop which aimed to promote consistency among test laboratories. First it went through the risk management requirements specified in IEC 60601 and then presented the tools available to all laboratories participating in the IECEE CB Scheme.
As a result of the meeting and the workshop, a series of recommendations and proposals was laid out for approval by the IECEE CMC (Certification Management Committee) at its next meeting in June 2009. These recommendations include ongoing development of guidance for implementing the risk management process particularly as regards the content of the Risk Management File prepared by the manufacturer; the assessment of the Risk Management File; and the reporting of the assessment outcome into the relevant part of the Test Report Form.
A further outcome of the meeting and workshop was the need for additional specific training for laboratory staff, manufacturer testing laboratories, and technical assessors. The Task Force requested a specific workshop early in 2010.
The question of how to deal with collateral standards to IEC 60601-1 was also raised. In the 60601 series of publications, collateral standards specify general requirements for safety applicable to either a group of medical electrical equipment (e.g. radiological equipment) or a characteristic specific to all medical electrical equipment (e.g. electromagnetic compatibility) not fully addressed in the general standard, IEC 60601-1.
The Task Force proposed to develop guidance documents for these collaterals and made a recommendation to the CMC defining a consistent approach for the handling of assessments to collaterals.
Software evaluation
The next two days, 16-17 April, were devoted to the “Software Evaluation” workshop, a premiere for the IECEE.
Software controlled oven
Household appliances and multimedia equipment for the home, for example, are two categories of products that rely more and more on software that may be a critical element of the product itself or may play an essential role in its safety. This trend is developing rapidly, as is the need for expertise in evaluating such products.
In its report to the CMC at the IECEE annual meetings in Jeju, Korea in 2008 (see the July 2008 e-tech), the IECEE ACAG (Assessment & Certification Advisory Group) drew attention to this issue, recognizing that IECEE technical assessors, and by extension, CBTL staff, have limited experience and skills in software evaluation. To remedy the situation, the ACAG made some recommendations to the CMC, notably to prepare guidelines and organize a workshop to help interested parties – NCBs (National Certification Bodies), CBTLs, technical assessors – acquire the skills essential to software assessment. To that end, the ACAG proposed to seek and recruit experts in that field, who could contribute and impart their knowledge by giving lectures at the workshop. The CMC approved the ACAG recommendation and a workshop was planned for April 2009.
The “Software Evaluation” workshop provided the audience with a series of presentations on all types of issues pertaining to software evaluation, and seen from different perspectives: industry, IEC TC experts, conformity assessment.
Presentations and the discussions that followed all emphasized the obvious need to harmonize views and reach a common understanding and a common practice to assist all parties in dealing with software evaluation. The general conclusion was to set up a specialized TP (Technical Panel) that could provide stakeholders with such a global approach, and thus facilitate trade. This TP would be composed of the experts who gave lectures during the workshop, joined by other leading experts in the software evaluation field, who would work closely with the IECEE’s CTL ETF 1 (Committee of Testing Laboratories’ Expert Task Force 1): Household appliances. It was further decided that all documents and guides issued by the Software Evaluation TP would have to be endorsed by the CTL prior to their submission to the CMC.
