Essential Performance (EP) initially came into the IEC 60601 series of standards when the 3rd edition of IEC 60601-1:2005 was published. The definition was quite confusing and many manufacturers, regulators and test houses had a hard time with it and how to apply it properly. In 3rd edition (2005) + amendment 1 (2012) some clarification came into play which made it easier to understand but there is still a fair amount of confusion.

About 2 years ago a test lab did some research and brought up the issue that a significant number of test reports (a high percentage of them) of critical devices didn’t define essential performance appropriately to the Sub Committee SC62A on “Common aspects of electrical equipment used in medical practice”. From this research, an ad-hoc group was formed to come up with a solution.

The initial solution was to come up with this Interpretation Sheet (ISH) to explain Essential Performance (clause 4.3 which is not as clear as the ISH but for those that know the standard have been doing it this way for years) and Single Fault Condition (SFC) (clause 4.7) that is related to Essential Performance. Access a copy thru the IEC website if you know where to find it or the easier route is to download it here. Note, this document doesn’t cover all the issues about Essential Performance as it is a complex situation but it does help explain some of the issues involved. The ISH per IEC requirements is limited to 2 pages of written text of explanation allowed by IEC requirements and so has a constraint on how detailed it can get. It is good for explaining the concept for the General standard IEC 60601-1, edition 3.1 which covers also ed. 3.2 (no change there). The General standard concept is based on limits but for some Particular standards (IEC 60601-2-XX or IEC/ISO80601-2-XX), limits don’t work for all products applicable (not all display-based product that the clinical function is based on the display function for example). But the ISH doesn’t really get into the details of how EP deals with Particular standards much (covered a little in the ISH) so that really needs to be looked at further still.

So, what is the next step? This ad-hoc group with the help of some additional people in the standards development community (I hope to be in this group) will start in the next couple of months (probably after the IEC TC 62 General meeting of April 12 – 23, 2021) to work on a guidance document to provide further guidance on EP as I still find that many regulators around the world, test labs, and manufacturers all have varying understanding of what EP & SFC are.

This varying understanding has a huge impact on projects as if say the test lab asks the manufacturer what their EP is, the manufacturer may say I don’t have any, the test lab will check the test report form (TRF) as none. When gets to say FDA the first thing FDA would ask is why is there no EP on the device? If found out there is EP the client would have to retest under the applicable IEC 60601-1, Particular (60601-2-XX/80601-2-XX) and Collateral Standards (60601-1-XX) + the EM Disturbances standard IEC 60601-1-2 which would add cost and time delays to a project.

Need help with Essential Performance. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at Leo@EisnerSafety.com.

A reminder that FDA Guidances and Recognized Consensus Standards are voluntary.  But I remind my clients’ that if you don’t use these voluntary documents for premarket submissions you make your life and the reviewer’s life a lot harder, typically.  So, I recommend, in most cases, to use these voluntary documents to speed up the process, in the long run.  In the short run, you may need to do more testing but if you don’t you risk the chance of your product not being accepted by the FDA.

The Guidance goes on to say that “the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device under review, as well as the use of appropriate FDA-recognized standards or appropriate consensus standards.”  The Guidance indicates that manufacturers typically reference in premarket submissions Recognized consesnsus national (US) and international standards such as IEC 60601-1-2²) (3rd or 4th edition) Medical Electrical Equipment EMC standard, device specific Particular Standards such as IEC 60601-2-XX, and lastly they reference other consensus standards for electrically-powered deevices that include information on EMC such as ISO 14708³ for active implantable medical devices.

The Guidance continues with a listing of details that FDA is expecting manufacturer’s provide in their premarket submissions, so the medical device EMC information is clear and consistent information for the submission, and are consistent with the specifications included in the standards, as referenced above, that are applied to the premarket submission.  The Guidance points to the FDA Recognized Consensus Standards database located at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

The rest of the Guidance, Section II “EMC Information”, details the list of items the FDA is expecting of the manufacturer’s for premarket submissions.  And of course the FDA leaves an opening for a broad statement at the end of the section that says: “Additional information not outlined above may be requested by FDA depending on intended use and intended use environment for specific active medical devices (e.g. implantable portions of active devices) to demonstrate the device’s claims regarding electromagnetic compatibility (EMC).”

If you need help with this FDA Draft Guidance or with IEC 60601-1-2 edition 3 or edition 4 or you are interested in our new Eisner Safety Consultants Standards Reconnaissance Database please email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

^{Footnotes cited from FDA Draft Guidance Document issued on 2 Nov 2015 titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”}

<sup>1. According to International definitions, “disturbance” is the cause and “interference” is the effect. In the US, “interference” is often used interchangeably for both cause and effect though more often for the cause. 
2. IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, IEC 60601-1-2:2014 [4th Ed.], Medical Electrical Equipment, Part 1 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests, AAMI/ANSI/IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, and AAMI/ANSI/IEC 60601-1-2: 2014 [4th Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests 
3. ISO 14708-3 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators</sup>

We also set-up pages to do the same for checking on the status of the IEC 80601 series of current & draft standards, which are standards that are jointly developed between IEC & ISO, and TRFs of the current 806012 series standards.  These later standards are called either IEC 80601-X-Y standards or ISO 80601-X-Y standards.  The lead organization gets their organization initials in the standards identifier.

This is a great resource to be able to stay up to date on the standards that are being developed, the updates to current standards and to ensure your standards library is up to date as required under ISO 13485 and also under most medical device regulatory national schemes.  If your organization needs help keeping track of current &/or developing standards our organization can help you develop a system or we can do this work for your organization’s standards and external documents library.  Please feel free to contact us about this at Leo@EisnerSafety.com or 503-244-6151.

Currently, HC recognizes both 2nd & 3rd edition of IEC 60601-1.  Based on what has been published, before this notice, after June 1, 2012 HC would only accept IEC 60601-1, 3rd ed. with the related Collateral standards (i.e. IEC 60601-1-XX that are aligned with IEC 60601-1, 3rd ed.) and related Particular standards (i.e. IEC 60601-2-XX that are aligned with IEC 60601-1, 3rd ed.).  This doesn’t work well as there are some Particular standards that aren’t aligned with 3rd ed., as of yet, or that have only recently (in the last year or so) been published by IEC and so many manufacturers haven’t had the time and/or resources to understand the requirements, do any redesign work, update to their labeling, update their Risk Management File to meet IEC 60601-1, 3rd. ed with any related Collateral & Particular standards, prepare the product for testing (including gathering all appropriate information [component info, etc.] to support the testing), test the product that will hopefully show that the manufacturer complies with all the requirements of the IEC 60601-1, 3rd ed. and the applicable Colateral and Particular standards.  That is unless the manufacturer has a lot of resources and are on top of the standards as they are being developed thru IEC and are starting on all this work prior to the applicable standards being published.

So, this HC guidance document sets out the following for the transition rules to be applied as of June 1, 2012:

1. If there is no Particular standard that is directly applicable to the device, it should conform to IEC 60601-1:2005 and its applicable Collateral standards.
2. If there is a Particular standard(s) that is directly applicable to the device and the version that aligns with IEC 60601-1:2005 was published by IEC before June 1, 2009, then the device should conform to IEC 60601-1:2005 and its applicable Collateral standards in addition to the(se) Particular standard(s).
   NOTE: If there are multiple Particular standards that apply to the device you will want to take the latest Particular standard publication date and if that is still before June 1, 2009 use this item 2.  If it is after June 1, 2009n then use item 3.
3. If there is a Particular standard(s) that is directly applicable to the device and the version that aligns with IEC 60601-1: 2005 was published by IEC after June 1, 2009, a three year transition period from the date of publication by IEC will apply.  During this transition, HC will accept conformity to both editions and related Collateral standards (and both will be listed on HC’s List of Recognized Standards).  
   Refer to NOTE in item 2. 

These transition rules will not be applied retroactively, meaning that if you have a HC Medical Device License for your product and you used IEC 60601-1, 2nd ed. unless there is a significant change to your product that impacts the characteristics of IEC 60601 series of standards you won’t have to retest to IEC 60601, 3rd ed and submit for an Amended License Application.  HC doesn’t require meeting the ‘state of the art’ in the same sense as is stated in the Essential Requirements of Annex I in the EU Medical Device Directive (MDD) or similarly in the Active Implantable Medical Device Directive (AIMDD) so the manufacturer only needs to submit to HC when they have a new medical device that requires a HC license or the manufacturer has to amend their HC medical device license because they have significant change(s) to the product(s) that impact characteristics addressed by the 60601 series of standards.

You still can submit for a HC Medical Device License to 2nd edition of IEC 60601-1 before June 1, 2012 but you will need to make sure it is shipped prior to June 1, 2012.

Standards are voluntary per the CMDR so if you have test data to IEC 60601-1, 2nd ed. and the applicable Particular & Collateral Standards you still could submit this test data to HC after the Transition Rules (items 1 – 3 above) prescribe IEC 60601-1:2005 & applicable standards.  The mfr would have to provide a summary of the differences in the testing compared to IEC 60601-1:2005 and provide a rationale to demonstrate that these differences do not affect the validity of the testing in demonstrating of the device’s safety and effectiveness.

The guidance document does state that HC reserves the right to require additional testing deemed necessary to demonstrate safety and effectiveness of any device. 

A very important note is stated near the end of the document which says:

” A Medical Device Licence issued by Health Canada provides authorization to import or sell a medical device in Canada and is evidence that the device meets the requirements of the Medical Devices Regulations.  Manufacturers are reminded that Provincial or Territorial electrical safety requirements are separate and distinct from the requirements of the Regulations.  For further information regarding these requirements, contact the applicable regulatory authorities.  A listing of some such authorities is available at: http://www.csa.ca/cm/ca/en/community/electrical/regulators.”

I (as a medical device consultant, US TAG member of IEC SC 62A & 62D & Convener of SC62D JWG9 {IEC/ISO/AAMI/CENELEC 80601-2-58} and a Notified Body Auditor) am really pleased to see the extremely hard work that has gone into this document and also in the value that it will pass on to all the stakeholders.  There are many stakeholders that were involved in this process including Notified Bodies, NB-MED EN 60601-1:2006 issues team (Thank you for your hard work.), NB-MED, Manufacturers, OEMs, Power Supply Manufacturers, Standards Developers for EN & IEC & other national standards bodies, Test Houses, Consultants, other countries regulatory bodies (i.e. FDA, Health Canada, etc.) and more.  By use of so many different stakeholders that submitted some of these and other questions this document has a much more consistent view on the implementation issues with the complexity of a series of more than 60+ EN 60601 standards.  It is expected that this document will get revised again but when that will happen is not clear at this time.  I would assume once Amendment 1 (A1) to EN / IEC 60601-1:2006 / 2005 is released approximately end of 2012 / Sept 2012 there will be more implementation questions in addition to the ones in section 3.9 (Q & A 3.9.1 thru 3.9.5 related to A1) of this excellent resource.

This document is good for learning about your specific implementation issue(s) or if you have the time I would highly recommend reading the whole document, as this will help you understand the intricacies of some of the situations of implementing EN 60601-1 with respect to the MDD (I’m sure there are more issues but a good portion have been captured by this first version).  I believe this document would be of great help to implement similar guidance documents for many other national medical device regulatory agencies around the world that are transitioning to the 3rd edition of IEC 60601-1:2005 (or their national version of the standard).

The Table of Contents gives a good glimpse into the realm of the issues covered in this document and covers the following topics.  I also provide a further glimpse into the document by summarizing some of the specific issues within those sections (these are the indents furthest to the right):

• History (background of how we got to this point and document)
• Introduction (Section 1 – document intended to clarify many questions as related to implementation of EN 60601-1:2006 within the EU under the MDD)
• Abbreviations (Section 2)
• Questions and Answers (Section 3 – Primary purpose of the document)
• Process how to place products on the EU market (Section 3.1)
• Explain ‘placing med dvc on the market’ in EU; If med dvc doesn’t change, regulation hasn’t changed, why need provide different evidence with new Harmonized Std; are harmonized stds mandatory; do you have to retest to 3rd ed, when product been on the market for years;  why bother with transition date 1 June 2012 when my EC certificate has a 2014 expiration date; does the product in a distribution center equal ‘placed on the market’; Medical Electrical Equipment(MEE)  met 2nd ed. & breaks down after transition period what std applies now for replacement MEE; why does EU require 3rd ed. compliance with new & legacy products;

• Transition process in general (Section 3.2)
• Is use of newest Harmonized stds even if product hasn’t changed after transition date; Would it have been better to have all the stds in the 60601 series have the same transition period; Is there the bandwidth for all the testing that will be required by the EN 60601-1:2006 deadline of 1 June 2012 (for only 3rd ed. without particular stds) that it may hit a critical point;
• Application of EN 60601-1 (Section 3.3)
• Does EN 60601-1:2006 apply to AIMD products; Are mechanical rqrts of 3rd ed. applicable to non-active products; power supply questions – external pwr supply compliant to 2nd ed., pwr supply approved against EN 60950 (ITE equipment), pwr supply part of a complete 2nd ed. compliant medical electrical equipment, my pwr supply mfr isn’t ready for 3rd ed. yet – my options; What do if applying to several countries and the other country(ies) requires 2nd ed. vs 3rd ed. in EU; EN 62304 in relation to 3rd ed. of EN 60601-1; software development issues; if for some reason major redesign needed to meet 3rd ed. are there smart ways to deal with this; how obtain test protocol TRF version G of 3rd ed.; is there a 3rd ed. delta list available for evaluation of an approved 2nd ed. product
• Role of collateral standards (Section 3.4)
• Are Harmonized Standards binding; what happens to collateral stds (i.e. EN 60601-1-XX) that have been integrated into 3rd ed. of 60601-1; how deal with collateral stds that don’t have an edition aligned with 2nd ed. of EN 60601-1 (i.e. EN 60601-1-11 & -1-12)
• Role of particular standards (multiple or late particulars) (Section 3.5)
•  multiple stds related to x-ray; if x-ray equipment has interventional & non-interventional procedures do both EN 60601-2-43 & -2-54 apply; some particular stds that don’t references 3rd ed. of 60601-1 what happens then; is compliance with 3rd ed. required after 1 June 2012 even if part 2 std won’t be released til after transition period; how deal with EN 13544-1:2007 + A1:2009 which is aligned with 2nd ed. of EN 60601-1 and currently there is no development of a 2nd ed. of EN 13544-1; van every kind of IEC or ISO std act as a particular std
• Transition period of EN 60601-1:2006 (Section 3.6)
• Should there be a 3 year transition period for brand new particular standards Harmonized per the Directive {i.e. EN 60601-2-XX}; particular stds with a transition period ending after 1 June 2012; transition date known for EN 60601-2-49; transition issues with EN 60601-2-43; how deal with EN 60601-2-2 & -2-10 which have different transition dates
• Duties of Notified Bodies (Section 3.7)
• ZLG paper 3.5 A1; How an N.B. audit of technical file or design dossier of product that hasn’t started the process, or plan set-up but not start testing, or partially start testing
• Application of Risk Management (Section 3.8)
•  What are the different roles of the applicable stakeholders in this process including the mfr., Notified Body, test house, etc.; equivalent safety (clause 4.5 of 60601-1 3rd ed.); how to deal with the differences between EN 14971:2001 (equivalent to ISO 14971:2000) and EN 14971:2007; mapping rev. G of TRF  for IEC 60601-1:2005 with Risk Management documentation that is required per EN 60601-1:2006
• Amendment 1 related questions (Section 3.9)
• Amendment 1 of 3rd edition of IEC & EN 60601-1 will be published approximately Sept 2012 & around end of 2012.  This is a major amendment with more than 100 changes some very minor and some that will mean more work for the manufacturers to prove compliance and some changes that will benefit the manufacturer.  It is recommended to review the A1 as soon as you can get your hands on it to see what type of impact it will have on you.
• References (Section 4)
• Recommendation for usage (Section 5)
• Applicability of horizontal and role of particular standards (multiple or late particulars) for use in combination with IEC/EN 60601-1, 3rd.ed with respect to X-ray equipment (Annex 1)
• General – applicability of standards (Annex 1, section 1)
• Categorization of X-ray equipment related to its intended use and applicable standards (status 2012-01-20) (Annex 1, Section 2)
• Summary (Annex 1, Section 3)

On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information can be found on our blog post on this topic.

On March 4th  join Leo Eisner in Foster City, CA as he & several other presenters focus on the topic of “Evolving Risk-Based Regulatory Requirements” for a whole day workshop put on by RAPS (SF Bay Area Chapter) & ASQ (Biomedical Division Northern CA Discussion Group).  Leo will be presenting on the 3rd ed. of IEC 60601-1, the series of standards, and also the impact of change on the medical device industry.  Other topics will include Usability & Human Factors verification, validation, and regulatory requirements; and Clinical evaluation & investigation regulatory requirements. More information can be found on our blog post on this topic.

Download all our newsletters at http://www.EisnerSafety.com/esc-news/

Summary:
This issue is packed full of important updates and useful information. First, we are going to focus on additional updates with regard to IEC/EN 60601-1:2005/2006 as there is significant news since the last issue of our newsletter.

Next we delve into the MDD Amendment 2007/47/EC specifically on the updated Classification MEDDEV and the new Clinical Data requirements. We also would like to remind you when your EU MDD Notified Body is up to reviewing your technical file or design dossier you need to make sure you have addressed the Usability and Clinical Data requirements as they apply to all medical devices under the MDD Amendments. If you need help with these new requirements to the MDD we have a toolkit that will be helpful to you.

Lastly, our Associate Christine Ruther writes about an FCC publication in regard to medical devices that use inductive coupling to recharge batteries.

We hope you enjoy this edition of the newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

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The current document posted on 22 March 2010 is an update to the previously posted document issued 9 October 2009 on the CENELEC site

The newest document has added in a few critical issues including

• that with the publication of EN 60601-1:2006, compliance with EN 60601-1:1990 and its related collateral standards will no longer give ‘presumption of conformity’ with the European directives covered as of 1 June 2012.  This date 2012 was confirmed by the CENELEC Technical Board in October 2009 (decision D135/C228). Publication in the Official Journal of the European Union is necessary for this decision to enter into force. The publication of the 1 June 2012 date is expected in spring 2010.
• devices should not be presumed to be unsafe simply because they were designed to comply with EN 60601-1:1990 when first introduced into the European market. Whether or not the safety of such devices represents the “state of the art” can only be determined through the application of Risk Management according to EN ISO 14971 and especially with regard to Clause 9 thereof.
• For those medical devices for which a part 2 exists (i.e., a standard labeled EN 60601-2-x or EN 80601-2-x), the transition period for that part 2 is decisive.  If the transition period of the part 2 ends, for example, on 21 November 2011 then, after this date, compliance with the old (‘superseded’) standard no longer gives the presumption of conformity with the Essential Requirements covered by the standard. In this situation, the 1 June 2012 date is not relevant.
• and more CENELEC site link