FDA Recognizes IEC 60601-1 Edition 3.2

FDA Recognizes IEC 60601-1 Edition 3.2

On April 3, 2023 FDA added IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment – Part 1: General requirements for basic safety and essential performance to their list of Recognized Consensus Standards as Recognition # 19-49 in Recognition List

FDA Adds Interpretation Sheet 1 on Essential Performance & SFC of IEC 60601-1 to AAMI ES60601-1 Recognitions DB

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

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

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