{"id":3765,"date":"2014-04-15T18:18:23","date_gmt":"2014-04-15T18:18:23","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3765"},"modified":"2014-04-15T18:18:23","modified_gmt":"2014-04-15T18:18:23","slug":"can-an-osha-nrtl-certify-to-ansiaami-es60601-12005r2012-with-amendments-yet","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2014\/04\/15\/can-an-osha-nrtl-certify-to-ansiaami-es60601-12005r2012-with-amendments-yet\/","title":{"rendered":"Can an OSHA NRTL Certify to ANSI\/AAMI ES60601-1:2005\/(R)2012 with Amendments Yet?"},"content":{"rendered":"

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This article discusses OSHA’s release of ANSI\/AAMI ES60601-1:2005\/(R)2012 + Amendments & timing of @ least 1 NRTL\u2019s authorization to use it.<\/span><\/p>\n

On 27 March 2014 OSHA announced thru a Federal Register Final Notice<\/a><\/strong> that they are incorporating new test standards into the list of \u2018Appropriate NRTL* Program Test Standards\u2019<\/a><\/strong>.\u00a0 With this<\/span><\/span> announcement they have officially added the US medical electrical standard \u201cANSI\/AAMI ES60601-1:2005\/(R)2012 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance <\/strong>(with amendments)<\/strong><\/a>\u201d as an \u2018Appropriate NRTL Program Test Standard\u2019. \u00a0The 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. \u00a0<\/span><\/p>\n

*NRTL =\u00a0Nationally Recognized Testing Laboratory.\u00a0<\/span><\/p>\n

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This version of the standard is currently the US National Version of IEC 60601-1:2005 + Amendment 1:2012 (A1) + Corrigendums + Interpretation Sheets\u00a0+ US National Deviations.\u00a0 When I checked with my contact at OSHA he indicated that OSHA tries to make references to the \u2018Appropriate NRTL Program Test Standards\u2019 so as to \u201cFuture Proof\u201d 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 \u201cAppropriate Standard\u201d.\u00a0 He said it this way \u2018I was not involved with writing the FR notice, but I suspect it was written that way to future\u00a0proof the approval of the standard.\u00a0 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. \u00a0Had we announced the specific amendment numbers it would have locked us into that specific version.\u00a0 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.\u00a0 The important thing for us was we were not recognizing the original issuance of the AAMI standard, only A1 and later.\u2019 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<\/a><\/strong>) and of November 25, 2013 (OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards<\/a><\/strong>) OSHA never liked the original version of US version of IEC 60601-1:2005 (3rd<\/sup> edition) but instead once A1 came out with its 496 changes (for the IEC standard) \u00a0that made the standard easier to use and more sensible that made all the difference in the world to OSHA.\u00a0<\/span><\/p>\n

So, if you want to get a US NRTL Mark on your product to this standard you will have to update to 3rd<\/sup> 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.\u00a0 With FDA you have some time before 3rd<\/sup> edition with A1 is required (stayed tune for further details in a future post) as you can use 3rd<\/sup> edition without A1 until August 1, 2016 (as noted in FDA\u2019s Recognized Consensus Standards List under Recognition Number 5-78<\/a><\/strong> Supplemental Information Sheet (SIS) \u201cANSI\/AAMI ES60601-1:2005\/(R)2012 and C1:2009\/(R)2012 and A2:2010\/(R)2012\u201d).\u00a0 You are also allowed to used 3rd<\/sup> edition<\/span><\/span> with A1 with FDA using Recognition Number 5-77<\/a><\/strong>.\u00a0 A reminder that the Recognized Consensus Standards<\/a><\/strong> are not mandated to be used and are voluntary.\u00a0 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.\u00a0 It was invented a long time ago so why put yourself thru all this extra work?<\/span><\/p>\n

Are We There Yet OSHA?<\/span><\/h2>\n

When I checked in with my contact on 27 March about the Federal Register Final Notice<\/a><\/strong>\u00a0he indicated \u2018that at least one lab has applied for recognition to AAMI ES 60601-1\u2019 and that their \u2018\u2026policy 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.\u2019\u00a0 He also noted: \u2018Organizations 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.\u2019\u00a0 I went onto the OSHA NRTL website to see how many labs have UL 60601-1 currently as an \u2018Appropriate\u2019 Standard for their labs and of the 15 NRTL\u2019s that exist 10 of them are approve d for this standard.\u00a0 The NRTL\u2019s that have UL 60601-1 as an \u2018Appropriate\u2019 Standard are noted in the below listing.\u00a0 From the links in this listing you can click on them to go to the NRTL\u2019s list of approved standards and also the locations of their test labs that fall under the NRTL program.:<\/span><\/p>\n