IEC 6 is not part of the Amendments Project. IEC 6, the remaining standard of the Project was published in September. (For background on the Amendments Project, refer to my previous article, “The Future of the IEC 60601 Series: An Update,” published in the In Compliance 2020 Annual Reference Guide.) Six of the standards that fall under the Amendments Project were published in July 2020, and IEC 60601-1 was published in August. The Amendments Project under SC62A covers the general standard (IEC 60601-1) and most of the collateral standards (IEC 60601-1-XX, except for IEC 6). There are literally hundreds of changes in these standards, and it would be impossible to adequately provide details on all of these changes.īut we’ll do our best in the pages that follow. The article provides a summary of some of the changes from the previous version of the standards impacted by the Amendments. This article will focus on the IEC 60601 series of medical electrical standards, and specifically on the IEC Amendments Project, a project that was completed under Sub Committee 62A (SC62A). Ultimately, this impacts the manufacturer’s quality systems and technical documentation, increases product development cycle times, and stretches out product time to market. As a result, it is becoming more difficult for medical device manufacturers as well as medical device consultants to keep up to date with the proliferation of changes. Medical device standards are being developed more and more rapidly and some existing standards are being updated in shorter time frames (i.e., the rules for IEC standards development has changed to allow for shorter development cycles), and national medical device regulations (including guidances) keep changing at a faster pace. Part of our work is reflected in the recently released Ed. Most recently, I have been involved in four of the standards committees dedicated to IEC 60601-1, Medical electrical equipment, one of eight standards in the IEC Amendments Project. O ver the many years of my career, I have noticed that standards keep changing at an ever-increasing rate. Make Plans Now to Start Your Gap Assessment

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