This post discusses NRTL’s approved for AAMI ES 60601-1 3^rd 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 3^rd 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  Once UL formally announces that UL 60601-1 will be withdrawn will OSHA take steps to withdraw that standard from their list of Approved Standard so that could a long time from now as I have not heard any word that UL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 3^rd 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 3^rd edition by itself without the amendment and that is why it took so long before OSHA allowed a US based version of 3^rd 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 3^rd 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 3^rd edition + Amendment 1?

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:

So, once the 2nd list of 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). 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:

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 Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

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).

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 (3^rd 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 3^rd 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 3^rd edition with A1 is required (stayed tune for further details in a future post) as you can use 3^rd 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 3^rd 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.:

• Canadian Standards Association (CSA)
• Curtis-Straus LLC (CSL)
• Intertek Testing Services NA, Inc. (ITSNA)
• MET Laboratories, Inc. (MET)
• QPS Evaluation Services Inc. (QPS)
• SGS North America, Inc. (SGS)
• TUV Rheinland of North America, Inc. (TUV)
• TÜV SÜD America, Inc. (TUVAM)
• TÜV SÜD Product Services GmbH (TUVPSG)
• Underwriters Laboratories Inc. (UL)

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 3^rd edition or 2^nd 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: Leo@EisnerSafety.com.  We have several associates that can assist with this type of work.

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BIG News!!!  News, I have been waiting for many years now is that OSHA, finally, under it’s NRTL (Nationally Recognized Test Lab) program will be adding the US National version of the IEC 60601-1:05 + A1:12 medical electrical safety standard (= AAMI ES 60601-1:05/(R):12 + A1:12 + C1:09/(R):12 + A2:10/(R):12) to their ‘List of Appropriate’ NRTL Program Test Standards.  The announcement in the Federal Register is dated for 25 November 2013 but the list won’t be updated until at least early next year as comments, information, & documents in response to the notice, or requests for extension of time to make a submission are due by 26 December 2013.

What’s that mean to those manufacturers that have been waiting years to get a NRTL US Mark for their medical electrical product to 3rd ed. of 60601-1?  It means that OSHA is just announcing they are adding this standard to the ‘list of Appropriate Standards’ sometime early next year, if things run smoothly.  But does that mean the Test Agencies like UL, CSA, TÜV SÜD, & Intertek that have previously asked OSHA to add the US national version of 3rd ed. of the IEC 60601-1 standard to these lab’s ‘list of Appropriate’ standards will be automatically added to that list?  My guess, at this point, is that OSHA will have to qualify each test lab that wants to be added to this list for AAMI ES 60601-1.  How long will this take?  And what will that qualification look like as now OSHA has to deal with qualifying the safety test agencies for the review and approval of the risk management process for medical electrical devices (a new concept for them I would suspect), among other potential issues?  That’s a good set of questions and I have an e-mail into OSHA to ask all these types of questions and when I get some feedback from them I will send an update out to all of you.  

Note, the Notice in the Federal Register had a fairly major typo, which I already pointed out to my contact, and that is the notice should have identified the standard as AAMI ES 60601-1:05/(R):12 + A1:12 + C1:09/(R):12 + A2:10/(R):12 (this is the US National version of IEC 60601-1:05 + A1:12) and instead they had a big set of typos that says in this notice “AAMI ES 60601-1” (they missed all the details to id it as Amendment 1 – Ooooops) and the title they refer to is “Medical Electrical Equipment—Part 1-2: General requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Compatibility (third edition)”.  The items that are underlined, bolded and italicized are the wrong standard name.  And I believe they should be very specific for this version of the standard and that is why I am pointing out the full AAMI ES identifier in this post and sending it to my contact at OSHA. He already said they are checking into the typos.  Hopefully the typos can be fixed quickly so that it doesn’t slow down the process anymore.

So, hopefully by mid next year, or hopefully before then, OSHA will be able to say they have one or more of the NRTL’s online for issuing NRTL safety agency marks as that will mean those safety test agencies will be able to start to issue the NRTL mark to the AAMI ES 60601-1:05/(R):12 + A1:12 + C1:09/(R):12 + A2:10/(R):12 version of the standard.  So, another question comes up will the Safety Agencies be able to leverage from previous testing done by these Safety Test Agencies or will they need to start a totally new test project before they can issue the NRTL mark for this standard?  I will make sure that OSHA get’s all these questions and hopefully they will be able to respond to these questions and answers publicly.  That I really am not sure about yet. 

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: Leo@EisnerSafety.com.  

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1)    When the FDA extended the transition period for the Recognized Consensus Standard IEC 60601-1:2005 + A1:2012 (US National Version) from June 30, 2013 to the end of this year to Dec 31, 2013.  They did so FDA could align with the OSHA NRTL program (Nationally Recognized Test Lab program – a program where OSHA authorizes certain test labs for specific test standards to issue a Safety Agency Mark under the NRTL program) for this standard.  Some time in May ’13 OSHA finally relaxed their opposition to the use of the US National Version of IEC 60601-1, 3^rd ed., but this has not been publicly announced yet.  In the last couple months OSHA has been planning to announce that they would start to authorize a couple test labs under the US national version of IEC 60601-1:2005 + A1:2012 before the end of this year.  But OSHA hasn’t publicly announced, via the Federal Register, it’s intentions yet.  It is known throughout industry that OSHA plans on authorizing test labs to the AAMI version of IEC 60601-1:2005 (3^rd ed.) + A1:2012 specifically with A1 incorporated with 3^rd ed.  OSHA believes that 3^rd ed. doesn’t meet the requirements of the NRTL law as the manufacturer is considered involved in the testing of the device since the manufacturer puts the Risk Management File together for the test lab to review which contradicts what the NRTL law allows.  Per the law the test lab has to conduct all the testing.  For some reason OSHA is ok with the US version of IEC 60601-1:2005 + A1:2012 and doesn’t believe it violates the law so they are planning to announce starting the authorization process of a few test labs to authorize them under the 60601-1:2005 + A1:2012 (US version) by the end of the year.  Even if the announcement happens shortly it is unlikely OSHA will be able to authorize 1 or more labs by the end of the year.  Will FDA need to extend the transition period again or will they want to again?  That is a big question we will have to wait and see what happens.

2)    On June 14, 2013 FDA released a draft guidance document for the Management of Cybersecurity in Medical Devices.  FDA decided the 60601-1 guidance should also consider the Cybersecutiry Guidance document as 60601-1 is about medical electrical equipment which means most of these types of devices would be impacted to some degree by cybersecurity issues.

3)    Lastly, FDA is working with NIST to try and align Conformity Assessment programs for 60601-1 testing so that the EU & the USA can harmonize this process.  This is based on a USA EU Free Trade Agreement that has spurred this process on.

What are some of the issues the draft guidance will cover?  The guidance will most likely include how the FDA will view and expect the manufacturer to deal with the Risk Management File requirements of 3^rd ed. + A1 of 60601-1, the FDA draft guidance on Cybersecurity, and now that A1 was published back in Aug of 2012 FDA they will want to consider any changes that impacts the guidance document as FDA will only be accepting 3^rd ed. + A1 after Dec 31, 2013.  These are the things that I have knowledge of and I am sure I could speculate more but won’t for now as this document has been such a moving target for so long.

You may be interested in another blog post I have written related to these issues:

FDA Extends AAMI ES 60601-1 Transition Date to 31 Dec ’13 & Other Important Changes – Recognition Lists 031/032

If you need any support with FDA and the AAMI ES 60601-1 standard we would be happy to assist you. Let us know what we can do to help your company be successful in this transition with FDA.  Contact Leo Eisner by e-mail or call us at 503-244-6151.

From what I have determined the change in transition date is based on that OSHA’s NRTL (Nationally Recognized Test Laboratories) Program will be aligning with the FDA in terms of this standard and will hopefully be by the end of this year, if not sooner, they will be able to approve NRTL Test Labs to the US National Version of IEC 60601-1, 3^rd ed. which probably will be ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text).  FDA has been intending to, and I hope they do, come out with a guidance document for premarket submissions of medical electrical equipment and what their expectations are for applying the US National Version of IEC 60601-1, 3^rd edition.  Also, about 1-1/2 months ago FDA announced their concern about cyber-security for medical devices and hospital networks and so they issued a Safety Communication on June 13, 2013 to medical device manufacturers, hospitals, medical device user facilities, health care IT & procurements staff; & biomedical engineers; and they issued a draft guidance document on the issue on June 14, 2013.  To coordinate all these activities, draft guidance documents, and agencies FDA decided to extend the transition period for the US National version of IEC 60601-1, 3^rd ed. equivalent.

The IEC 60601 series of standards that FDA has Listed in the Recognized Consensus Standards Listing and some of the ISO 80601 series of standards that FDA has listed are updated in List 031 with this new transition date, unless it is a brand new standard being published on the List for the first time, along with other changes that were ready to be published.  The Cyber-security standards are listed in Recognition List 032 and are all new listings to the List of Recognized Consensus Standards.  There were many other changes with these Recognition Lists 031 & 032 which will officially be published in the Federal Register as of 6 August 2013 and the changes will officially be effective then but have already been issued prior to August 6, 2013 in the FDA’s Recognized Consensus Database. (Either one or two days prior).

Below is a summary of the more critical changes, from my perspective, for List 031.

New Standards Added to the FDA’s Recognition List 031 (Table 2 of List 031) of significance are:

There were also modifications to the List of Recognized Stds (Table 1 of List 031) of some importance.  The 60601 related standards were updated to align with the transition period of ANSI/AAMI ES60601-1 std along with other changes of importance as noted below.

In a future blog post we may discuss Recognition List 032 and the Cyber-security standards.

If you have any questions or if you would like our assistance with regard to these standards please feel free to contact us at Leo@EisnerSafety.com.