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FDA Finally Adds to Fall 2020 Recognized Consensus Standards db for Cycle Update

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

IEC 60601 Amendments Updates Have Published: Changes and Impacts

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 Just Released – Join for a Webinar on Changes & More

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

Insider’s look at the IEC 60601 Amendments: detailed guidance from committee member responsible for changes

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

New IEC 60601 Collateral Standards Published Early

Big News!!! IEC published ahead of schedule 6 of the 8 standards from the IEC 60601 Amendments Project. These standards are in Consolidated format meaning the latest edition plus amendments are all consolidated together. IEC notes this as a CSV.