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A good summary article on IEC e-Tech News about the IEC 60601 Series Amendments project that published last summer (2020) the General 60601-1, and Collateral standards (60601-1-XX). Please note that you need to read further comments in some of my articles about IEC 60601-1 for IEC 62368-1 and IEC 60601-1-2 for some additional details. One blog post is an article from InCompliance
Updated 22 Dec 2020 – In the last couple of years, the FDA has started to post the standards updates on their Recognized Consensus Standards db prior to publishing in the Federal Register (FR). This year, being the year we
In the November issue of InCompliance Magazine I discuss the IEC 60601 Amendments Project, which includes the IEC 60601-1 General standard and the Collateral standards (IEC 60601-1-XX standards but for IEC 60601-1-3), and some of the changes to the General and Collateral
IEC 60601-1 Amendment 2 (IEC 60601-1:2005 +A1:2012 + A2:2020) has been in the making since 2015 (officially) along with the other published Amendments (IEC 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, & 60601-1-12). It was published on 20 August 2020 on the
It’s becoming increasingly more difficult for medical device manufacturers and consultants to stay up to date with the proliferation of changes in the regulatory landscape. With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that