Several NRTLs, who are currently recognized for UL 60601-1, have applied to OSHA to add ANSI AAMI ES60601 + Amendment 1 to their scope of recognition.  OSHA is currently reviewing these applications and anticipates the final recognition for these NRTLs to be granted in late summer.

Some of the NRTL’s have completed the technical review process and demonstrated that they have the capability to test and certify to the AAMI standard.  For these NRTLs, the preliminary Federal Register notice has been drafted and OSHA is expecting to see these in the Federal Register in the near future (could be a couple weeks or a month or two). 

As this is an expansion of their scope these NRTL’s are subject to a 15 day notice and comment period where members of the public will have an opportunity to comment on OSHA’s intent to recognize these organizations for the AAMI Standard.  At the conclusion of the 15 day comment period, OSHA will draft a second and final notice, addressing any comments OSHA receives from the public, and announce OSHA’s final decision in the Federal Register.  Once these second FR notices are published, the NRTLs named in the notice will be considered recognized for the AAMI standard. 

So, once the NRTL’s are Recognized for the AAMI ES 60601-1, for 3^rd + Amendment 1 these NRTL’s will finally be authorized to allow their clients, after passing the applicable testing for their product(s), to place a US NRTL Test Mark on their client product(s).

If you need additional support for AAMI ES 60601-1 or IEC 3rd edition + A1 email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).