摘要：Introduction. The increasing spread of software components in the healthcare contextrenders explanatory guides relevant and mandatory to interpret laws and standards, andto support safe management of software products in healthcare.Methodology. In 2012 a working group has been settled for the above purposes at ItalianElectrotechnical Committee (CEI), made of experts from Italian National Instituteof Health (ISS), representatives of industry, and representatives of the healthcare organizations.Results. As a first outcome of the group activity, Guide CEI 62-237 was published inFebruary 2015. The Guide incorporates an innovative approach based on the propercontextualization of software products, either medical devices or not, to the specifichealthcare scenario, and addresses the risk management of IT systems.Conclusions. The Guide provides operators and manufacturers with an interpretativesupport with many detailed examples to facilitate the proper contextualization and managementof health software, in compliance with related European and international regulationsand standards.
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