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 the documents noted below AAMI and ANSI finally has approved these Amendments in January and February 2022. They were all published in April 2022 (correction late March 2022). The Amendments are all identical adoptions of the IEC versions which were originally issued through IEC during June – Aug of 2020. The standards are available on the AAMI standards db and at the AAMI store (if your an AAMI member log-in for your member discount). The links below are to the AAMI store version of the standard which is just the latest Amendment only.

You’ll want to know about this as the FDA will Recognize has Recognized (see post on Recognition of these standards) all of these Standards as soon as they can get them added to their Recognized Standards db probably before the next full publication of the db.

• ANSI/AAMI ES60601-1:2005/A2:2021  Medical electrical equipment—Part 1: General requirements for basic safety and essential performance— Amendment 2 (Amendment 2 to IEC 60601-1:2005)

• ANSI/AAMI/IEC 60601-1-2:2014/A1:2021  Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests, Amendment 1 (Amendment 1 to IEC 60601-1-2:2014)

• ANSI/AAMI/IEC 60601-1-8:2006/ A2:2021 Medical Electrical Equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, Amendment 2 (Amendment 2 to IEC 60601-1-8:2006)

• ANSI/AAMI HA60601-1-11:2015/A1:2021 Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, Amendment 1 (Amendment 1 to IEC 60601-1-11:2015)

• ANSI/AAMI/IEC 60601-1-12:2016/A1:2021 Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment— Amendment 1 (Amendment 1 to IEC 60601-1-12:2014)

Need Help?

Need help with 60601 standards (Medical Electrical Equipment), work thru strategic planning for your medical electrical product lines, need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.