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Q&A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1

A Q&A post based on questions in the 25 Nov ‘13 post on OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards

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, 3rd 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, 3rd 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 1st quarter but suspect it will be more like end of 2nd 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.  1st quarter 2014 is possible (although very tight), but 2nd 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, 3rd 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 3rd ed. of 60601-1.  The process for the IEC Particulars and Collaterals standards incorporating the 60601-1, 3rd 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 3rd 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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