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