This article discusses OSHA’s release of ANSI/AAMI ES60601-1:2005/(R)2012 + Amendments & timing of @ least 1 NRTL’s authorization to use it.

On 27 March 2014 OSHA announced thru a Federal Register Final Notice that they are incorporating new test standards into the list of ‘Appropriate NRTL* Program Test Standards’.  With this announcement they have officially added the US medical electrical standard “ANSI/AAMI ES60601-1:2005/(R)2012 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (with amendments)” as an ‘Appropriate NRTL Program Test Standard’.  The ES60601-1 weblink goes to the AAMI online store for the standard for your convenience. This announcement is something that many of us in the medical device industry have been waiting for about 8+ years – since the publication of IEC 60601-1:2005 in Dec 2005.  

*NRTL = Nationally Recognized Testing Laboratory. 

This version of the standard is currently the US National Version of IEC 60601-1:2005 + Amendment 1:2012 (A1) + Corrigendums + Interpretation Sheets + US National Deviations.  When I checked with my contact at OSHA he indicated that OSHA tries to make references to the ‘Appropriate NRTL Program Test Standards’ so as to “Future Proof” it, that is to say they make the reference fairly broad so if there are updates to the standard, like a new amendment, they still would be able to list the Standard as an “Appropriate Standard”.  He said it this way ‘I was not involved with writing the FR notice, but I suspect it was written that way to future proof the approval of the standard.  When OSHA approves a standard, we typically don’t publish a new FR notice when the standard is revised or a new edition is published.  Had we announced the specific amendment numbers it would have locked us into that specific version.  By being a bit more generic, it allows AAMI to revise and update the standard and we do not need to publish a new FR notice every time it is updated.  The important thing for us was we were not recognizing the original issuance of the AAMI standard, only A1 and later.’ As I mentioned in my previous posts on this subject of January 11, 2014 (Q&A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1) and of November 25, 2013 (OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards) OSHA never liked the original version of US version of IEC 60601-1:2005 (3rd edition) but instead once A1 came out with its 496 changes (for the IEC standard)  that made the standard easier to use and more sensible that made all the difference in the world to OSHA. 

So, if you want to get a US NRTL Mark on your product to this standard you will have to update to 3rd ed. + A1 when there is a NRTL that is approved for this standard as you will see an estimated time frame later in this article.  With FDA you have some time before 3rd edition with A1 is required (stayed tune for further details in a future post) as you can use 3rd edition without A1 until August 1, 2016 (as noted in FDA’s Recognized Consensus Standards List under Recognition Number 5-78 Supplemental Information Sheet (SIS) “ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012”).  You are also allowed to used 3rd edition with A1 with FDA using Recognition Number 5-77.  A reminder that the Recognized Consensus Standards are not mandated to be used and are voluntary.  But I try to remind my clients if the Agency is used to reviewing to that Standard you are typically better off using this standard, even though voluntary, than starting from scratch and recreating the wheel.  It was invented a long time ago so why put yourself thru all this extra work?

Are We There Yet OSHA?

When I checked in with my contact on 27 March about the Federal Register Final Notice he indicated ‘that at least one lab has applied for recognition to AAMI ES 60601-1’ and that their ‘…policy is not to disclose who or how many have applied as we do not want to contribute to any business advantage or strategy that any NRTL may have or want.’  He also noted: ‘Organizations that already have UL 60601-1 in their scope simply need to demonstrate that they have the capability to evaluate and test the product in the areas that we identified as being significantly different.’  I went onto the OSHA NRTL website to see how many labs have UL 60601-1 currently as an ‘Appropriate’ Standard for their labs and of the 15 NRTL’s that exist 10 of them are approve d for this standard.  The NRTL’s that have UL 60601-1 as an ‘Appropriate’ Standard are noted in the below listing.  From the links in this listing you can click on them to go to the NRTL’s list of approved standards and also the locations of their test labs that fall under the NRTL program.:

Once OSHA’s NRTL Program reviews the Lab’s submission assuming an acceptable submission and the application is complete with minimal Q&A back and forth with the NRTL my contact says then they can do a ‘fairly quick review’ and if that is the case he is expecting ‘the preliminary [Federal Register] notice(s) around early May’ for this initial one or more applications.  He goes on to say: ‘with the final notice(s), officially recognizing the NRTL for the standard’ being issued in the Federal Register around ‘sometime in Mid-June’.  He also says ‘Others will follow later depending on when they applied and the completeness of the application.’

So, What Does This Boil Down To? 

This means that at least one of the NRTL’s, and possibly more, that previously had approval for UL 60601-1 has already submitted an application to OSHA to be approved as a NRTL under the newer ‘Appropriate NRTL Program Standard’ ANSI/AAMI ES60601-1:2005/(R)2012 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (with amendments) and if things go smoothly, as expected this one or possibly more labs will be able to test and certify to this standard and issue an OSHA NRTL Certification Mark for the US that the medical device manufacture will be able to place on their product.  For more than 8 years this has not been possible and it is likely we are talking til at least June if not a bit longer before it is formally announced through a Final Federal Register Announcement.

Examples of the NRTL US or US & Canada Marks are below (is not a complete list of NRTL’s that have approval for UL 60601-1):

So, are you ready for ANSI/AAMI ES60601-1:2005/(R)2012 + A1 yet?  If, not and you want a NRTL Mark on your device you should start looking at what you need to do to update from either 3rd edition or 2nd edition of the standard if you have previously had your product tested &/or certified to these versions of the standard.

Oppps a Mistake in the Announcement about Future Standards:

In the Final Notice OSHA mentioned the comments they received briefly and one of them was from Mr. Dale Hallerberg of TÜV Rheinland North America (OSHA-2013-0012-0007).  You can access all the comments to these notices right here. In Dale’s original comments he said “Correct the standard name in Table 1 to reflect the proper designations, title, and number. Also include all corrigendum and amendment(s). This will include the current A1 as well as possible future amendments.  ANSI/AAMI ES 60601-1 including corrigendum and amendment(s)”  There were a couple other people that commented about the standard reference being wrong in the preliminary notice. 

But more importantly Dale went on to say: ‘Include 60601-1 collateral and particular standards in Table 1. “Collateral standards to the 60601-1 base standard: 60601-1-2, -1-3, -1-6, -1-8, -1-10, -1-11, and -1-12 as appropriate for the workplace safety of the product. ANSI versions shall be used when they exist.”  And also he said ‘Since it is impossible to keep up an accurate (list) of all the particulars, add them in a general way as follows: “Particular standards to the 60601-1 base standard as appropriate for the workplace safety of the product. ANSI versions shall be used when they exist.”’  So, he is asking the OSHA NRTL program to allow the use all of the applicable 60601 series standards, for workplace safety, including the Collaterals (i.e. 60601-1-8 = Alarm system standard) and Particulars (i.e. 60601-2-18 Endoscopic camera medical devices standard).  He also asked that they shouldn’t have to be aligned with ANSI only.  Note, that OSHA has told me they will only use a US based standards development organization for the standards they list as ‘Appropriate’ and so that precludes any organization outside of the USA, such as IEC, ISO, CENELEC and CEN (European equivalents of IEC & ISO respectively) to name a few.

OSHA mistakenly printed the following text which has a few problems:

“Mr. Dale Hallerberg stated that the list of appropriate standards should include, in addition to ANSI/AAMI ES60601-1:2005/(R)2012, standards that are collateral to ANSI/AAMI ES60601-1:2005/(R)2012, such as ANSI/AAMI ES60601-1-2 through ANSI/AAMI ES60601-1-12 (OSHA-2013-0012-0007).”

  1. The first reference to “ANSI/AAMI ES60601-1:2005/(R)2012” doesn’t include the A1 which is critical to OSHA’s announcement as without A1 they would not be announcing this version of the standard.
  2. The big issue is there are no such standards as ANSI/AAMI ES60601-1-2 through ANSI/AAMI ES60601-1-12. The closest thing to any of these references is there is an AAMI standard for 60601-1-11 which is actually ANSI/AAMI HA60601-1-11:2011 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 (IEC 60601-1-11:2010, MOD).  The only other collateral standard that is issued thru AAMI via ANSI is ANSI/AAMI/IEC 60601-1-2:2007/(R)2012 (EMC).  Also, OSHA did not mention in the Final Notice Dale’s reference to the Particular standards.  It is hard to know if that was a mistake or if they intentionally left out the reference to the Particular Standards for some reason.

If your company needs help with edition 3.0 or 3.1 for AAMI ES 60601-1 or IEC or EN 60601-1 gap analysis, preparation of the risk management file for these versions of the standard, or training on the Standard, please contact Leo Eisner at: .  We have several associates that can assist with this type of work.

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Can an OSHA NRTL Certify to ANSI/AAMI ES60601-1:2005/(R)2012 with Amendments Yet?
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