June International Regulatory Updates for Canada, Saudi Arabia, EU, & US
June International Regulatory Updates
FDA Adds Interpretation Sheet 1 on Essential Performance & SFC of IEC 60601-1 to AAMI ES60601-1 Recognitions DB
The FDA on May 30, 2022, same day as when the recent AAMI 60601 Amendments were Recognized, added the Interpretation Sheet 1 (ISH1) – Amendment 1 – on Essential Performance (Clause 4.3) and Single Fault Condition (Clause 4.7) based on
AAMI Finally Issues 60601 Based Amendments
After a delay of over a year since the original US Technical Advisory Group IEC/SC62A & specific technical committees — Electrical Safety, Electromagnetic Compatibility, Alarms, and Home Care and EMS Environments committees — vote and an additional vote for each of
EU MDR & IVDR Harmonized Standards Lists Updated – 9 Added to MDR & 5 to IVDR
The European Commission published two Implementing Decisions: EU 2022/6 and (EU) 2022/15 for the MDR (EU) 2017/745 and IVDR (EU) 2017/746on 5 January 2022 and 7 January 2022 amending Implementing Decision (EU) 2021/1182 and (EU) 2021/1195 all above references are
IEC 60601 Amendments Presentation Now on MDG Premium
Joe Hage graciously invited me to present on July 30 to his MDG premium group on “IEC 60601 Amendments & What’s in the future for Medical Electrical Equipment”. We had a great conversation with about 35 or so people from around the world. They were from Ireland, the Netherlands, India, the US, and elsewhere in the conversation, with questions throughout and at the end too.