This post discusses NRTL’s approved for AAMI ES 60601-1 3rd ed. + A1 & can issue NRTL Marks vs which are in process.
There has been a lot of activity from OSHA with respect to the NRTL (Nationally Recognized Test Laboratory) program of late for medical device testing. UL 60601-1 is still an approved standard that an approved NRTL can issue a NRTL test mark too but a few of the NRTL’s have now been recently approved to issue a NRTL Mark to AAMI ES 60601-1 3rd edition + Amendment 1. Once UL formally announces that UL 60601-1 will be withdrawn will OSHA take steps to withdraw that standard from their list of Approved Standard so that could a long time from now as I have not heard any word that UL wants to withdraw the UL 60601-1 (equivalent to 2nd ed. of IEC 60601-1 + US National Deviations). Note, from several of my past blog posts OSHA has only allowed approved NRTL’s to use the standard AAMI ES 60601-1 3rd edition with Amendment 1 or with additional amendments to ‘future-proof’ the standard (Can an OSHA NRTL Certify to ANSI/AAMI ES60601-1:2005/(R)2012 with Amendments Yet? & Q&A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1 & OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards). OSHA did not like the standard AAMI ES 60601-1 3rd edition by itself without the amendment and that is why it took so long before OSHA allowed a US based version of 3rd ed. of IEC 60601-1.
The best place to confirm if a Safety Test Lab is an approved NRTL for the medical device standard AAMI ES 60601-1 3rd edition + Amendment 1 is by confirming the notifications published in the US Federal Register. The second best place is the OSHA NRTL website for the specifically approved NRTL. The reason why the NRTL website is my second source is it seems like it takes some time (i.e. several weeks to a month or so) for OSHA to update the site to get the most recently approved standards listed for the specific NRTL for the specific NRTL webpage.
So, which labs are currently approved to issue a NRTL Mark for the standard AAMI ES 60601-1 3rd edition + Amendment 1?
| Notice in Federal Register on: | Safety Test House Name |
| October 20, 2014 | Intertek Testing Services NA, Inc. (also known as ETL) |
| October 20, 2014 | MET Laboratories, Inc. |
| October 27, 2014 | Underwriters Laboratories, Inc. |
| December 22, 2014 | Curtis-Straus, LLC |
There are a couple other NRTL’s that are in process of being approved for this standard too but are not at the Final Decision Federal Register Announcement stage quite yet. They include:
| Notice in Federal Register on: | Safety Test House Name | Status |
| October 3, 2014 | TÜV SÜD America, Inc. | OSHA announced the application for expansion of its as a Nationally Recognized Testing Laboratory (NRTL) and presents the Agency’s preliminary finding to grant the application to add AAMI ES60601-1 to TÜV SÜD America, Inc.’s Scope of recognition |
| October 27, 2014 | SGS North America, Inc. | Same as above but for SGS North America, Inc. and for multiple standards including AAMI ES 60601-1. |
| December 22, 2014 | Nemko-CCL, Inc. (Salt Lake City, Utah) | Same as above but for Nemko-CCL, Inc. and for ANSI/AAMI ES60601-1: 2005/(R)2012 (the more recent publications for OSHA have used this reference vs AAMI ES 60601-1) and UL 60601-1. |
So, once the 2nd list of NRTL’s are Recognized for the AAMI ES 60601-1, for 3rd + 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). The first list in this blog post those NRTL’s are currently 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) to the ANSI/AAMI ES60601-1:2005/2012.
One additional piece of OSHA NRTL news is that I, Leo Eisner of Eisner Safety Consultants proposed to OSHA, on June 30, 2014, adding all current US based standards related to the US national standards of IEC 60601 series (AAMI standards). If you would like to read the letter with this list that was sent in to OSHA Read it here. Based on the letter I sent into OSHA a Federal Register Notice was issued on Nov 6, 2014 that proposed adding in all the standards I proposed (& a couple other non-related standards), with a close of comments date of December 8, 2014. The list of proposed standards is noted below from part of the Federal Register Notice:
|
Table 1—(Partial List of) Test Standards OSHA Is Proposing To Add to the NRTL Program’s List of Appropriate Test Standards |
|
|
Test standard |
Test standard title |
| AAMI HA60601-1-11 | 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. |
| AAMI 60601-2-2 | Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories. |
| AAMI 60601-2-4 | Medical electrical equipment—Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators. |
| AAMI 60601-2-16 | Medical electrical equipment,—Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment. |
| AAMI 60601-2-19 | Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators. |
| AAMI 60601-2-20 | Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators. |
| AAMI 60601-2-21 | Medical Electrical Equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers. |
| AAMI 60601-2-25 | Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs. |
| AAMI 60601-2-27 | Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment. |
| AAMI 60601-2-47 | Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems. |
| AAMI 60601-2-50 | Medical Electrical Equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment. |
| AAMI 80601-2-30 | Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. |
| AAMI 80601-2-58 | Medical Electrical Equipment—Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery. |
There were 2 comments on this specific notice. 1 comment was not related to the standards that I proposed and the other was specific to the list of standards I referred to. Curtis-Straus believes that the detailed list should not be added to the NRTL list of Approved Standards because the general standard ANSI/AAMI ES 60601-1:2005/2012(R) refers to the Particular and Collateral Standards of the 60601-1 series (letter attached) but they miss the point that not all of these standards have been developed and maintained by a US based SDO (Standards Development Organization such as ANSI, AAMI, UL, etc.) which is an OSHA requirement. But I requested these standards specifically because my OSHA contact indicated that no IEC 60601 series standards that aren’t specifically US based standards (i.e. developed by a US based SDO) can be used to issue a US NRTL Test Mark. So, if these US based medical device standard(s) are approved by OSHA the approved NRTL’s for those standards would be able to issue a US NRTL Mark for those standards once OSHA approves the Test Labs for this list of standards. I do not know based on Curtis-Straus’s comments what OSHA will do with this list now. I will check into the issue and report back on this topic.
If you need additional support for ANSI/AAMI ES60601-1: 2005/(R)2012 or IEC 3rd edition + A1 email Leo Eisner at , or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).