{"id":3591,"date":"2014-01-11T01:19:13","date_gmt":"2014-01-11T01:19:13","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3591"},"modified":"2014-01-11T01:19:13","modified_gmt":"2014-01-11T01:19:13","slug":"qa-on-osha-nrtl-for-aami-es-60601-1-3rd-ed-a1","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2014\/01\/11\/qa-on-osha-nrtl-for-aami-es-60601-1-3rd-ed-a1\/","title":{"rendered":"Q&#038;A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1"},"content":{"rendered":"<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">A Q&amp;A post based on questions in the <strong><a href=\"http:\/\/www.eisnersafety.com\/osha-to-add-aami-es-60601-1-to-list-of-appropriate-nrtl-program-test-standards\/\">25 Nov \u201813 post on OSHA to Add AAMI ES 60601-1 to \u2018List of Appropriate\u2019 NRTL Program Test Standards<\/a><\/strong><\/span><\/p>\n<p><!--more--><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">So, let\u2019s answer the questions from the <strong><a href=\"http:\/\/www.eisnersafety.com\/osha-to-add-aami-es-60601-1-to-list-of-appropriate-nrtl-program-test-standards\/\">previous blog post about the OSHA NRTL program starting to establish and adding in the AAMI ES 60601-1 Standard<\/a><\/strong>.\u00a0 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&amp;A.<\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">1) \u00a0The first question was: \u201cdoes that mean the Test Agencies \u2026 that have previously asked OSHA to add the US national version of 3rd ed. of the IEC 60601-1 standard to these lab&#8217;s &#8216;list of Appropriate&#8217; standards will be automatically added to that list?\u201d<\/span><br \/>\n<span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Additionally I asked: \u201cAnd 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?\u201d\u00a0<\/span><\/p>\n<ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The reply is \u201cno\u201d to the first question, they will not be automatically added in.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">If a lab didn\u2019t previously have UL 60601-1 in their scope, under the NRTL program, they wouldn\u2019t have been sent a <strong><span style=\"text-decoration: underline;\"><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2014\/01\/NRTL-letter-for-comparability_UL-60601.docx\" target=\"_blank\" rel=\"noopener noreferrer\">letter from the OSHA NRTL program explaining the process to be able to be considered to add the AAMI ES 60601-1, 3<sup>rd<\/sup> ed. + Amendment 1 standard to their \u2018List of Appropriate\u2019 Standards<\/a><\/span><\/strong>.\u00a0 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.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong><span style=\"text-decoration: underline;\"><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2014\/01\/NRTL-letter-for-comparability_UL-60601.docx\">This letter<\/a><\/span><\/strong>, 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 <strong><span style=\"text-decoration: underline;\"><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2014\/01\/NRTL-letter-for-comparability_UL-60601.docx\" target=\"_blank\" rel=\"noopener noreferrer\">is available here for your reference<\/a>.<\/span><\/strong>\u00a0 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<sup>rd<\/sup> ed. +A1 standard.\u00a0 My OSHA contact said <em><strong><span style=\"text-decoration: underline;\">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<\/span><\/strong><\/em>.\u00a0 This was surprising to me but once I understood his response I wasn\u2019t too surprised as I learned a lot about the program and the process by asking all these questions.\u00a0 My contact stated the following: \u201cWhile it\u201d [Risk Management] \u201cforms an important aspect of the standard, for OSHA\u2019s 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.\u201d<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">My contact summarized the process that the labs would go through to get authorized for the AAMI ES 60601-1 standard.\u00a0 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.\u00a0 \u201cOSHA 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.\u00a0 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.\u201d<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The <strong><span style=\"text-decoration: underline;\"><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2014\/01\/NRTL-letter-for-comparability_UL-60601.docx\" target=\"_blank\" rel=\"noopener noreferrer\">letter<\/a><\/span><\/strong> states the following important issues.\u00a0 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\u2019s \u2018List of Appropriate\u2019 standards:<\/span><\/li>\n<\/ul>\n<\/ul>\n<ul>\n<ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">\u201cOSHA believes that AAMI ES60601-1 is not completely comparable to UL 60601-1.\u00a0 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,\u201d<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">\u201cOSHA has evaluated AAMI ES60601-1 against UL 60601-1 and has noted the substantive differences between the two standards.\u00a0 To add this new standard to your scope of recognition [Test Lab Name] must provide evidence that they have addressed those substantive differences.\u00a0 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.\u201d\u00a0<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">\u201cAdding this standard to your scope is an expansion of your recognition.\u201d\u00a0 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.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Lastly, if the test lab decides not to apply to request the expansion prior to the removal of UL 60601-1 from OSHA\u2019s list of \u2018Appropriate test standards\u2019 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.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">My OSHA contact has indicated that when ANSI or UL has withdrawn UL 60601-1 the standard will be removed from OSHA\u2019s list of \u2018appropriate test standards.\u2019\u00a0 The letter just doesn\u2019t make reference to the US Standards Development Organizations (ANSI, UL, etc.) but says the same basic information.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">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).\u00a0\u00a0 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 \u2013 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 &#8211; this is the only test that the test lab may opt out of conducting the test if they don\u2019t have the capability), and Rough handling test (Sub-clause 15.3.5).<\/span><\/li>\n<\/ul>\n<\/ul>\n<\/ul>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">2) \u00a0\u201cHow long will\u201d the qualification process \u201ctake?\u201d \u00a0<\/span><\/p>\n<ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">When I talked to my contact at OSHA I expanded this question to the following: \u201cHow long will it take to first get the standard added to the \u201cAppropriate Standards Listing\u201d and then from there how long to get the first couple of labs qualified as a NRTL under AAMI ES 60601-1 + A1?\u00a0 I am hoping this can all turn around by end of 1<sup>st<\/sup> quarter but suspect it will be more like end of 2<sup>nd<\/sup> quarter.\u201d<\/span><\/li>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">His response was: \u2018The Final notice\u2019 (in the Federal Register) \u2018announcing the AAMI standard as an \u201cappropriate test standard\u201d is expected to be published sometime in January.\u00a0 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.\u00a0 1<sup>st<\/sup> quarter 2014 is possible (although very tight), but 2<sup>nd<\/sup> Quarter is very reasonable.\u2019<\/span><\/li>\n<\/ul>\n<\/ul>\n<\/ul>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">3) \u00a0I 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: \u201cNote that I checked the Federal Register announcement just now and it still shows the IEC 60601-1-2 standard title being the EMC standard.\u00a0\u00a0What is the plan for the new update to the 60601-1 + A1 standard title and standard number listing?\u00a0\u00a0Are 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?\u201d<\/span><\/p>\n<ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">My contact\u2019s response was: \u201cWe plan on issuing a formal correction in the Federal Register notice when we publish the final Federal Register notice (anticipated sometime in January).\u00a0 Once a FR Notice is published, you cannot amend it, you can only issue a correction in a separate notice.\u00a0 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.\u201d<\/span><\/li>\n<\/ul>\n<\/ul>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">4) \u00a0The last question I asked in my previous NRTL post was: \u201cwill 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?\u201d<\/span><\/p>\n<ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">My OSHA contact\u2019s response states: \u201cIt will be possible for the NRTLs to make use of some of the evaluation and testing conducted before they were recognized as an NRTL.\u00a0 NRTLs will need to formally document this review.\u00a0 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.\u201d<\/span><\/li>\n<\/ul>\n<\/ul>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">5) \u00a0After 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.<\/span><\/p>\n<ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">\u201cAs you know there are numerous particular standards pending review\/revision to reflect the new requirements introduced by A1\u201d [Amendment 1] \u201cof 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\u201d [as they aren\u2019t aligned to A1 of 60601-1 yet as they haven\u2019t been published yet.]. \u201cSo the majority of products cannot be certified to ed. 3.1 yet. \u00a0Does OSHA have any plans how they will deal with this issue&#8230;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)\u201d [Such as AAMI\/ANSI IEC\/ISO 80601-2-58]. \u00a0\u201cAre there any of the collateral and particular standards covered under a US SDO\u201d [Standards Development Organization] \u201clike ANSI or AAMI? \u00a0How will the OSHA NRTL program deal with the collaterals and the particulars\u2026?\u201d<\/span><\/li>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">My contact\u2019s response was: \u2018OSHA Regulations, specifically 29 CFR 1910.7(c), requires that test standards recognized under the NRTL program be \u201cRecognized in the United States as a safety standard providing an adequate level of safety\u201d\u00a0Historically, 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.\u00a0 If a collateral or particular standard has not been \u201cRecognized in the United States as a safety standard providing an adequate level of safety\u201d, it cannot be designated as an \u201cappropriate test standard\u201d under the NRTL Program.\u00a0 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\u00a0our 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).\u2019<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">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<sup>rd<\/sup> ed. + A1 to be added to the NRTL List of Appropriate Standards.\u00a0 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<sup>rd<\/sup> ed. of 60601-1.\u00a0 The process for the IEC Particulars and Collaterals standards incorporating the 60601-1, 3<sup>rd<\/sup> 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.\u00a0 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.<\/span><br \/>\n<span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong><em><span style=\"text-decoration: underline;\">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 \u201cappropriate standards\u201d.<\/span><\/em><\/strong><\/span><\/li>\n<\/ul>\n<\/ul>\n<\/ul>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">6) \u00a0Previous to the OSHA NRTL post I also asked my OSHA contact a question why they didn\u2019t use the 3<sup>rd<\/sup> 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.\u00a0 <\/span><\/p>\n<ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">His reply was: \u201cThe 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.\u201d<\/span><\/li>\n<\/ul>\n<\/ul>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">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:\u00a0<a href=\"mailto:Leo@EisnerSafety.com\"><strong>Leo@EisnerSafety.com<\/strong><\/a>. \u00a0<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Sign-up for our monthly newsletter to keep up to date on all our posts. \u00a0Go to the upper left hand corner of any page on the site and sign-up to enjoy articles like this. \u00a0Make sure to reply to the confirmation e-mail otherwise you won&#8217;t be signed up. (If you don\u2019t see that e-mail check your spa or junk mail folders).<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Q&amp;A post based on questions in the 25 Nov \u201813 post on OSHA to Add AAMI ES 60601-1 to \u2018List of Appropriate\u2019 NRTL Program Test Standards<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[61,15,403,41,163,27,94,22,330,174,149,43,1153,1087,1154],"class_list":["post-3591","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-60601-series","tag-60601-1","tag-a1","tag-aami-es60601-1","tag-ansiaami-es60601-1","tag-escnews","tag-iec60601-1-3rd-ed","tag-medical","tag-medical-device","tag-medical-device-industry","tag-medical-devices","tag-nrtl","tag-osha-60601","tag-osha-nationally-recognized-test-lab-program","tag-osha-nrtl"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3591","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=3591"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3591\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3591"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3591"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3591"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}