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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So, let’s answer the questions from the previous blog post about the OSHA NRTL program starting to establish and adding in the AAMI ES 60601-1 Standard.  Below are the questions I stated in the last blog post, on this subject, along with the replies from my OSHA contact and additional Q&A.

1)  The first question was: “does that mean the Test Agencies … 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?”
Additionally I asked: “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?” 

• The reply is “no” to the first question, they will not be automatically added in.
• If a lab didn’t previously have UL 60601-1 in their scope, under the NRTL program, they wouldn’t have been sent a letter from the OSHA NRTL program explaining the process to be able to be considered to add the AAMI ES 60601-1, 3^rd ed. + Amendment 1 standard to their ‘List of Appropriate’ Standards.  So, if there is a lab without UL 60601-1 in their scope they will need to contact OSHA directly to request a review be conducted to AAMI ES 60601-1, provide the appropriate information, and pay the review application fee.
• This letter, which was sent out the week of 16 Dec 2013 to the test labs that had UL 60601-1 in their scope when it was sent, and is available here for your reference.  It shows that the test labs that want to get approved for this new standard will need to provide some documentation to OSHA to prove they have the capability for meeting the differences from the UL 60601-1 standard to the AAMI ES 60601-1, 3^rd ed. +A1 standard.  My OSHA contact said they are not asking for any specific evidence that the test agency is capable of dealing with the Risk Management requirements of the AAMI ES 60601-1 standard.  This was surprising to me but once I understood his response I wasn’t too surprised as I learned a lot about the program and the process by asking all these questions.  My contact stated the following: “While it” [Risk Management] “forms an important aspect of the standard, for OSHA’s purposes, we believed that Risk management played a very small part in the overall electrical safety, and the capability necessary to look at risk management was similar to that used in other electrical safety standards.”
• My contact summarized the process that the labs would go through to get authorized for the AAMI ES 60601-1 standard.  Note this was written before the letter was issued so this is the general steps to the process of a test lab asking for an expansion of their List of Appropriate Standards.  “OSHA will be contacting NRTLs with UL60601-1 in their scopes, providing details of the information they will need to provide to request an expansion to AAMI ES 60601-1.  OSHA will review the application submittals, make a determination of acceptability, and publish a preliminary and final Federal Register notices before an NRTL can officially be considered recognized for AAMI ES 60601-1.”
• The letter states the following important issues.  Some of which the test labs will need to have reconciled before OSHA will add the AAMI ES 60601-1 standard to that test lab’s ‘List of Appropriate’ standards:

• “OSHA believes that AAMI ES60601-1 is not completely comparable to UL 60601-1.  Therefore, pursuant to the requirements in 29 CFR 1910.7(b)(1), OSHA will only modify the scope of recognition of [Test Lab Name] to include AAMI ES60601-1, if [Test Lab Name] submits information that demonstrates capability to those replacement test standards,”
• “OSHA has evaluated AAMI ES60601-1 against UL 60601-1 and has noted the substantive differences between the two standards.  To add this new standard to your scope of recognition [Test Lab Name] must provide evidence that they have addressed those substantive differences.  Table 1 contains a list of those requirements in AAMI ES60601-1 that differ substantively from UL 60601-1. [Test Lab Name] will need to submit information to demonstrate their capability to address these substantive differences.” 
• “Adding this standard to your scope is an expansion of your recognition.”  The cost to apply for the expansion review is only $300 but OSHA can invoice the test lab for any additional remaining fees before they announce the expansion when approved.
• Lastly, if the test lab decides not to apply to request the expansion prior to the removal of UL 60601-1 from OSHA’s list of ‘Appropriate test standards’ UL 60601-1 will be removed from the test labs scope and the lab will no longer be recognized to test or certify there type of products.
• My OSHA contact has indicated that when ANSI or UL has withdrawn UL 60601-1 the standard will be removed from OSHA’s list of ‘appropriate test standards.’  The letter just doesn’t make reference to the US Standards Development Organizations (ANSI, UL, etc.) but says the same basic information.
• Table 1 only covers 6 specific tests requirements OSHA is concerned with and 1 item specific to additional evaluation of lithium batteries (Sub-clause 15.4.3.4).   The 6 test requirements are for Acoustic Energy (Sub-clause 9.6), Pressure vessels and parts subject to pneumatic and hydraulic pressure (sub-clause 9.7.2 – 9.7.4), Pressure control device (Sub-clause 9.7.6), Mechanical hazards associated with support systems (Sub-clause 9.8), Oxygen Rich Environments (Sub-clause 11.2.1 – this is the only test that the test lab may opt out of conducting the test if they don’t have the capability), and Rough handling test (Sub-clause 15.3.5).

2)  “How long will” the qualification process “take?”  

• When I talked to my contact at OSHA I expanded this question to the following: “How long will it take to first get the standard added to the “Appropriate Standards Listing” and then from there how long to get the first couple of labs qualified as a NRTL under AAMI ES 60601-1 + A1?  I am hoping this can all turn around by end of 1^st quarter but suspect it will be more like end of 2^nd quarter.”
• His response was: ‘The Final notice’ (in the Federal Register) ‘announcing the AAMI standard as an “appropriate test standard” is expected to be published sometime in January.  NRTLs can submit an application for the AAMI standard at any time, and the ultimate date when NRTLs will be recognized depends to a great extent on the quality and completeness of the application, as well as when the application is actually received.  1^st quarter 2014 is possible (although very tight), but 2^nd Quarter is very reasonable.’

3)  I noted in the last post on this topic that OSHA had a major typo in the Federal Register notice so I asked this question of my contact: “Note that I checked the Federal Register announcement just now and it still shows the IEC 60601-1-2 standard title being the EMC standard.  What is the plan for the new update to the 60601-1 + A1 standard title and standard number listing?  Are you planning to use the full standard reference like I did in my blog post such 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) or what and when should this change show up in this listing or will it be a separate update?”

• My contact’s response was: “We plan on issuing a formal correction in the Federal Register notice when we publish the final Federal Register notice (anticipated sometime in January).  Once a FR Notice is published, you cannot amend it, you can only issue a correction in a separate notice.  Such a correction would take just as long to process as a Final notice, so the decision was made to include the correction in the final notice.”

4)  The last question I asked in my previous NRTL post was: “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?”

• My OSHA contact’s response states: “It will be possible for the NRTLs to make use of some of the evaluation and testing conducted before they were recognized as an NRTL.  NRTLs will need to formally document this review.  However, OSHA is only recognizing A1 and later, so any evaluation and testing done to AAMI ES 60601-1:05 will need to be at least partially re-examined and possibly retested to ensure that the requirements of A1 are fully complied with.”

5)  After my previous post on the OSHA NRTL issues I wrote to my contact at OSHA and asked some additional questions which are noted here for your reference as I realized there were some other pertinent questions to ask.

• “As you know there are numerous particular standards pending review/revision to reflect the new requirements introduced by A1” [Amendment 1] “of 3rd ed. and thus the AAMI ES 60601-1 ed. 3.1 (or 3rd ed. + A1) with the collaterals can only be used for products where such particulars are not applicable” [as they aren’t aligned to A1 of 60601-1 yet as they haven’t been published yet.]. “So the majority of products cannot be certified to ed. 3.1 yet.  Does OSHA have any plans how they will deal with this issue…Do you plan to add any US national collaterals (60601-1-XX) and/or if there are any US national particular standards (60601-2-XX)” [Such as AAMI/ANSI IEC/ISO 80601-2-58].  “Are there any of the collateral and particular standards covered under a US SDO” [Standards Development Organization] “like ANSI or AAMI?  How will the OSHA NRTL program deal with the collaterals and the particulars…?”
• My contact’s response was: ‘OSHA Regulations, specifically 29 CFR 1910.7(c), requires that test standards recognized under the NRTL program be “Recognized in the United States as a safety standard providing an adequate level of safety” Historically, this has meant that the standard has been developed or adopted by a US based Standards Development Organization (SDO) which were often designated as an ANSI or ASTM standard.  If a collateral or particular standard has not been “Recognized in the United States as a safety standard providing an adequate level of safety”, it cannot be designated as an “appropriate test standard” under the NRTL Program.  In other words, unless the IEC60601-1-XX and IEC 60601-2-XX standards are developed or adopted by a US SDO, we are unable to include them as appropriate test standards for the NRTL program under our current regulations. If particulars or collaterals are adopted by a US SDO, and the standard is requested to be reviewed as an appropriate test standard as part of an expansion request by an NRTL, or by an industry/trade group, or another stakeholder, OSHA will review the standard to ensure that it meets the requirements in 29 CFR 1910.7(c).’
• His response basically means that OSHA has not considered any additional US Based SDO standards in the 60601 series based on the AAMI ES 60601-1, 3^rd ed. + A1 to be added to the NRTL List of Appropriate Standards.  There are no IEC and therefore AAMI or ANSI/AAMI standards in the 60601 series that have been published yet that include A1 of 3^rd ed. of 60601-1.  The process for the IEC Particulars and Collaterals standards incorporating the 60601-1, 3^rd ed. + A1 changes into these standards is just about to start in the development process and so it will take a year or so before they are published as International Standards.  Only a portion of them will be published as US based standards, if the lead for that group is run through the US national committee, either at the same time or after the IEC standard is published.
  So when these IEC based standards finally are updated to include the A1 changes and if they are also developed under a US SDO you could request that the OSHA NRTL program consider reviewing that specific standard to be added to the list of “appropriate standards”.

6)  Previous to the OSHA NRTL post I also asked my OSHA contact a question why they didn’t use the 3^rd ed. without the Amendment 1 as that could have been done a long time ago and then a NRTL mark could have been used now for many years. 

• His reply was: “The Concerns we had with the original issuance of AAMI ES 60601-1 were the numerous subjective compliance requirements, as well as statements in the standard that would have required the NRTL to accept statements from the manufacturer without the ability for the NRTL to verify the validity of these statements. The text of the standard therefore directly conflicted with the NRTL program requirements, which require the NRTL to make the final decision on testing and certification decisions. The changes in language introduced in A1 allowed the NRTL to accept data from the manufacturer, and verify the validity of that data. When we first reviewed AAMI ES 60601-1, we noted several areas that conflicted with the NRTL Program requirements, and the changes made in A1 aligned almost exactly with the clauses where we had concerns.”

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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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.

View the press release on the NEMKO website.