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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Last summer Amendment 1 (A1) came out and if you haven’t yet you should start learning about those changes as they will be impacting you sooner rather than later (sign-up for an FX Conferences recording of my recent presentation on A1 of IEC 60601-1 and its’ impact on users, follow the instructions to get a $50.00 discount, and sign up for the presentation titled “IEC 60601–1, 3rd Edition, Amendment 1 and its Impact on Users”) and also A1 can help you as it will reduce the amount of Risk Management File work you need to do for a product safety certification or approval. There are about 25 less Risk Management File requirements when using A1 vs using 3^rd ed.  To understand the differences and changes of A1 it is highly recommended that you get the IEC 60601-1 edition 3.1 (consolidated) edition as that shows you where all the changes are to the text vs 3^rd ed.  Note, when you submit for testing thru a test lab you will either want to use either edition 3.1 or 3^rd ed. but you can’t mix and match as that would not work well and any CB scheme certified lab, among most other labs, will not mix and match requirements as it gets messy quickly.

So, what are the current changes to the standards related to alignment with 3^rd ed. & the new Interpretation Sheet?  Let’s start with the standards.

The updates are actually withdrawal of two standards that have been embedded into 3^rd ed. when it was released (i.e. IEC 60601-1-1, 2^nd edition – Medical Electrical Systems & IEC 60601-1-4 Programmable Electrical Medical Systems) and so the 2^nd ed. aligned standards needed to be withdrawn as 2^nd edition of IEC 60601-1 has been withdrawn since the publication of 3^rd edition back at the end of 2005.  The withdrawal report to IEC for IEC 60601-1-1, Edition 2.0 (now in IEC 60601-1, 3rd ed. in clause 16) covered the following 3 points, and it is the same circumstances for IEC 60601-1-4, edition 1.1 (1^st ed. + A1) (now in IEC 60601-1, 3rd ed. in clause 14):

• IEC 60601-1 Ed. 2.2 (IEC 60601-1:1988+A1:1991+A2:1995) was withdrawn in 2005, yet those who want to use it have been able to do so for the past seven years.
• IEC 60601-1 Ed. 2.2 makes normative reference to a number of supporting standards that have been revised or superseded, yet users have been able to find the versions they need to implement Edition 2.2.
• With the changes made in Amendment 1 to IEC 60601-1:2005, there are substantive technical differences between this collateral standard and its respective clause in IEC 60601-1 Ed. 3.1. Therefore, this document can no longer be considered to represent the generally accepted state of the art.

Let’s move onto the Interpretation Sheet 3 (or IS3) for IEC 60601-1 3^rd edition and also for edition 3.1 or 3^rd edition + A1.  It is the 3^rd interpretation sheet issued since IEC 60601-1, 3^rd edition has been issued.  IS3 is a clarification of the requirement for sub-clause 13.1.2, 4^th dashed line which the sub-clause is titled “Emissions, deformation of ENCLOSURE or exceeding maximum Temperature”.  The requirement of concern is:

“The following HAZARDOUS SITUATIONS shall not occur;”

“- ….”
“-     temperatures of ME EQUIPMENT parts that are not APPLIED PARTS but are likely to be touched, exceeding the allowable values in Table 23 when measured and adjusted as described in 11.1.3;”  (This is the fourth dashed line of 13.1.2)

So, this requirement is saying that this situation should not occur (following HAZARDOUS SITUATIONS) if there is a part that isn’t an APPLIED PART (An APPLIED PART is a part of the device that in NORMAL USE necessarily comes into physical contact with the PATIENT for the device to perform its function.  So, a part other than an APPLIED PART) that is likely to be touched that exceeds the temperature limits of Table 23 (Allowable max temperatures for ME EQUIPMENT parts that are likely to be touched) in the temperature test method described in sub-clause 11.3.

The IS3 gives an alternative route to meeting the above requirement by stating the following:

“This is clarified by the following:

The above requirement is regarded as fulfilled in accordance with Subclause 4.5 for temperatures at the surfaces of the enclosure, if the following conditions are fulfilled:

− The maximum allowed temperature on OPERATOR accessible surfaces in SINGLE FAULT CONDITION is 105 °C; and

− the instructions for use contain a warning that, under some SINGLE FAULT CONDITIONS, the temperature of: (indicate the surface of concern) could get hot and there is a possible RISK of a burn if touched, and

− if the RISK ANALYSIS demonstrates a need for a warning symbol on the ENCLOSURE, safety sign ISO 7010-W018 ( ) shall be used on or adjacent to the hot spot on the ENCLOSURE; and

− the RISK ASSESSMENT demonstrates that the temperature attained in the SINGLE FAULT CONDITION is acceptable, and

− the RISK ASSESSMENT demonstrates that applying the alternative RISK CONTROL measures in this Interpretation Sheet results in a RESIDUAL RISK that is comparable to the RESIDUAL RISK resulting from applying the requirement of the standard.

NOTE 1 This Interpretation Sheet is intended to be used with both Edition 3.0 and Edition 3.1 of IEC 60601-1.

NOTE 2 An example of an analysis that demonstrates an adequately low probability of occurrence of HARM is shown below.”

To access this IS3 for free please go to the IEC website link.

If you need assistance with this or other issues, please contact us at Leo@EisnerSafety.com.

What’s it about:  The FDA published its draft guidance on Design Considerations for Devices Intended for Home Use in December of 2012, as part of an initiative started back in April 2010 “to support the safe use of medical devices in the home.” The guidance document is a significant step forward helping manufacturers understand the design criteria, user environments to consider, environmental considerations, and labeling issues. It also looks at other standards and FDA guidance manufacturers should consider, as well as post-market considerations, and other vital aspects of designing and developing devices that are intended to make the devices safer and easier to use.

Join us for this timely and informative audio conference presentation as our speaker takes attendees on a guided tour of the draft guidance. The presentation reviews the key points of the document as it relates to the IEC 60601-1-11 standard (Home Use Medical Electrical Equipment), human factors and usability (user environment), environmental considerations, labeling, and design controls (including risk management).

This audio conference will cover:

• Variations in the definition of home-use device under FDA and IEC 60601-1-11
• How the draft guidance relates to FDA’s Medical Device Home Use Initiative
• Environmental considerations discussed in the draft guidance
• User environments to be considered
• Key elements to keep in mind when designing home-use devices
• Labeling considerations
• Post-market considerations
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

It’s just under one week away from this big presentation.  I (Leo) have been working tirelessly to get the presentation in tip top shape and there will be lots of helpful information in the PowerPoint presentation.  So, sign-up now to take away a really useful summary document of the more important changes to IEC 60601-1 under Amendment 1 changes.

What’s it about:  Amendment 1 (A1) to IEC 60601-1, 3rd edition was published 13 July 2012 to help reduce the confusion surrounding the use of IEC 60601-1, 3rd ed.  A1 is a significant improvement to the standard and clarifies the use of new concepts in the 3rd Edition such as more detailed information on how to implement the risk management process and the process for identifying what is essential performance. It also helps resolve issues in some of the test requirements.

Join us for this audio conference presentation and ease your regulatory stress as Leo guides you through the significant A1 changes to the 3rd Edition!
This audio conference will cover:

• Changes to risk management requirements under Amendment 1
• Changes to essential performance and examples of essential performance
• Changes to test requirements
• Additional labeling issues, including changes to electronic labeling requirements
• Best documents to use to understand the differences between 60601-1, 3rd Edition and 60601-1, 3rd edition A1:2012
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

Leo Eisner will be speaking on “IEC 60601–1, 3rd Edition, Amendment 1 and its Impact on Users” at an FX Conferences event on May 2, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern).  You don’t have to leave your office to join in on the presentation and as a special thank you for visiting us at Eisner Safety Consultants you can get a $50.00 discount.

What’s it about:  Amendment 1 (A1) to IEC 60601-1, 3rd edition was published 13 July 2012 to help reduce the confusion surrounding the use of IEC 60601-1, 3rd ed.  A1 is a significant improvement to the standard and clarifies the use of new concepts in the 3rd Edition such as more detailed information on how to implement the risk management process and the process for identifying what is essential performance. It also helps resolve issues in some of the test requirements.
Join us for this audio conference presentation and ease your regulatory stress as Leo guides you through the significant A1 changes to the 3rd Edition!
This audio conference will cover:

• Changes to risk management requirements under Amendment 1
• Changes to essential performance and examples of essential performance
• Changes to test requirements
• Additional labeling issues, including changes to electronic labeling requirements
• Best documents to use to understand the differences between 60601-1, 3rd Edition and 60601-1, 3rd edition A1:2012
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

What’s it about:  Amendment 1 (A1) to IEC 60601-1, 3rd edition was published 13 July 2012 to help reduce the confusion surrounding the use of IEC 60601-1, 3rd ed.  A1 is a significant improvement to the standard and clarifies the use of new concepts in the 3rd Edition such as more detailed information on how to implement the risk management process and the process for identifying what is essential performance. It also helps resolve issues in some of the test requirements.
Join us for this audio conference presentation and ease your regulatory stress as Leo guides you through the significant A1 changes to the 3rd Edition!
This audio conference will cover:

• Changes to risk management requirements under Amendment 1
• Changes to essential performance and examples of essential performance
• Changes to test requirements
• Additional labeling issues, including changes to electronic labeling requirements
• Best documents to use to understand the differences between 60601-1, 3rd Edition and 60601-1, 3rd edition A1:2012
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

The end of the transition period for 2^nd ed. of IEC 60601-1 is June 30, 2013.  By July 1, 2013 I hope you will be using the 3^rd ed. based standard for your FDA premarket submissions declarations of conformity.  Are you ready for this transition period and where is the transition information located?

The answer is that the IEC version of 60601-1 isn’t a Recognized Consensus standard after the end of the transition period for 2^nd ed. of IEC 60601-1.  FDA will allow the 2nd ed. of IEC 60601-1:1988 + A1: 1991 + A2:95 (Recognition Number 5-4, Recognition List #013) up til the end of the transition period of June 30, 2013 but the transition period isn’t noted in this entry of the Recognized Consensus Standards list.  So, where do you suppose it is located?  One could search for a very long time and not come up with the answer, as the FDA database for Recognized Consensus Standards is not flexible when it comes to search terms.  You need to know to search for the US national version of the standard, which is the AAMI ES version.  Also, the entries for the 3^rd ed based US national version of IEC 60601-1 vs. the 3^rd ed. + A1 national version of IEC 60601-1 aren’t in the database the same way.  One is in the database as ‘ES60601-1’ and the other is ‘ES 60601-1’.

So, as of now you can start to use the ANSI/AAMI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012, including the A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment – Part 1: General requirements for basic safety and essential performance [Recognition Number 5-71, Recognition List #029] OR ANSI/AAMI ES 60601-1:2005/A1:2012 [Recognition Number 5-74, Recognition List #030] Recognition list #030 was issued on 15 Jan ’13.  Up to and thru June 30, 2013 you can also use the 2^nd ed. of IEC 60601-1 [Recognition Number 5-4, Recognition List #013].  In the Extent of Recognition section of both ES 60601-1 standards you will find a sub-section titled “Transition:” which states:

“FDA recognition of Edition 2:1988 (A1:1991+A2:1995) of IEC 60601-1 is hereby superseded by recognition of ANSI/AAMI ES60601-1:2005, Medical Electrical Equipment – Part 1: General requirements
for basic safety and essential performance. FDA will accept declarations of conformity, in support of premarket submissions, to Edition 2:1988 (A1:1991+A2:1995) of IEC 60601-1 until June 30, 2013. After this transitional period, declarations of conformity to Edition 2:1988(A1:1991+A2:1995) of the standard will not be accepted.”
Note, the text of the transition for both of the ES 60601-1 standards is the same.

If you company needs support dealing with the IEC 60601 series of standards, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval we can provide you with regulatory, product safety, standards compliance, quality system services and more.  Please feel free to contact us at Leo@EisnerSafetty.com or 503-244-6151.   

Either way this is a great resource and is useful to get a grip on the breadth of changes made for A1 and also if you are still getting your feet wet with 3^rd ed. of IEC 60601-1 (many companies are still just starting along this process) there are still items that were in 1st ed. of IEC 62348 that are still of great resource to you.  

With the release of A1 of IEC 60601-1 on July 13, ‘12 (consolidated edition 3.1 published Aug 20, ’12) & the US National Version ANSI/AAMI ES 60601-1:2005/A1:2012 there were a significant number of changes made to the 60601-1, 3^rd edition.  There were 182 identified issues and a total of 496 discrete changes to the 3^rd ed. of 60601-1, which included some significant changes, moderate changes, and some minor typos, as well.  Each of the 496 changes that A1 made were accessed by the developers of the standard to determine the impact on the users of 60601-1.  Many of the changes are only editorial corrections or clarifications so many of the changes (413 changes) were accessed as having minimal or no impact on the application of the standard.  But there were 83 changes that were accessed as having a moderate to significant impact on the users of the standard.  So, IEC TR 62348 “Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition” (here forward will only refer to IEC version as ANSI/AAMI/IEC TIR 62348:12 is the same as no technical changes to the document, just US national version introductory page changes) was updated for the 2^nd edition to add in the Assessment of the impact of these 83 changes, as noted in the title of the standard, and still keep the comparison between 2^nd to 3^rd ed. of IEC 60601-1.  The A1 assessment portion of the Technical Report is split into 2 parts based on the Significant (Table 1) or Moderate (Table 2) Impact on the users of the standard.  This assessment is based on the likelihood that some alterations to the design documentation, testing, the product itself, or its accompanying documents will be required because of the change to a requirement in the A1.  Further within each table the impact is sliced a bit thinner by considering if the issue will Impact many users or impact only particular users like a mechanical requirement that a chunk of devices may not be impacted by.  As these assessments are subjective users of the standard (IEC 60601-1:05 + A1:12) are highly encouraged to review the contents of the A1 and determine its impact on the sections that are relevant to their products.   The easiest way to read the A1 document is the consolidated A1 by IEC as the changes that can be shown are identified in a different color.  The IEC version of the consolidated version (edition 3.1) of IEC 60601-1:2005 + A1:2012 standard can be obtained thru TechStreet.  For the AAMI pdf go to the AAMI standards store and for the print version click here.

The first edition of IEC TR 62348 was originally set up to compare 2^nd to 3^rd ed. of IEC 60601-1 so for those going from 2^nd to 3^rd ed. the document was accessible to any that wanted to learn what type of changes were made and what clauses changed, stayed the same or similar, were new or disappeared.  Also, this document used to be free on the IEC website.  As of the 2^nd edition publication the document isn’t free anymore.  You can purchase the 2^nd ed. of IEC TR 62348:212 or AAMI/IEC TIR 62348:12 from various sources such as TechStreet or AAMI.