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
FDA Swiftly Recognizes AAMI 60601 Amended Standards 30 May 2022
The FDA in a little over a month on 30 May 2022 (that is swift) has updated the Recognized Consensus database for the AAMI 60601 Amendmended Standards that are referenced in my previous post of May 13, 2022. The AAMI