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
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
We’re Moving Offices
Please note as of 6 May 2022 you will no longer be able to contact us at: 3331 SW Seymour StreetPortland, Oregon 97239 We’ll be disconnecting our office phone line (503) 244-6151 permanently “cutting the cord”. Use the cell number