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So, you can get to the important areas for you I have split this blog into several sections that you can jump too quickly by clicking on the below links:

• When did the IEC 60601-1 A1 come out?
• What is the status of the EN 60601-1 A1?
• Is EN 60601-1:06 + A1:13 Harmonized under the MDD Yet?
• What about all the other EN 60601 series of standards?
• So, what is Annex ZA about?
• And what about Annex ZZ?

When did the IEC 60601-1 A1 come out?

Amendment 1 (A1) of IEC 60601-1:2005 (3^rd ed.) was published last summer on 13 July 2013 and the consolidated edition (edition 3.1 = IEC 60601-1:2005 + A1:2012) was published on 20 August 2012.  The consolidated edition is very useful as it shows all the redlines of the 496 changes that were made for A1 vs the original 3^rd ed.

What is the status of the EN 60601-1 A1?

So, for Europe it has taken over a year to get the EN (European Norm) of A1:2013 to EN 60601-1:2006 (third edition) to be ratified by CENELEC which was on 24 Sept 20013, then it became available for publication (Date of Availability) in Europe on 4 October 2013 and so now it is allowed to be published in Europe and must be implemented or published by all of the EU countries by 24 June 2014.  The only country that I have been able to find it published in is Denmark as a Dansk Standard (DS or in English it would be Danish Standards).  It is DS/EN 60601-1:06/A1:13 issued on 15 October 2013.

Is EN 60601-1:06 + A1:13 Harmonized under the MDD Yet?

The answer is a no, not yet but we are getting pretty close to it occurring.   It hasn’t been Harmonized yet but soon it will be approved as a Harmonized Standard.  This document tells a lot of the story for the history of the Harmonization process for EN 60601-1:06 + A1:13.  This version of the standard has been reviewed and approved for harmonization by the Consultants so its only a matter of publishing it in the Official Journal of the EU (OJ).

What about all the other EN 60601 series of standards?

If you read thru the document referenced in the previous paragraph you will find there are 41 total 60601 series standards in the pipeline that are all expected to flood out of the OJ as Harmonized Standards under the MDD by the end of the 1^st quarter of 2014.  That’s a lot of change to come in a short period of time.  But realize that is not the full series of 60601 standard out there & note there are Joint IEC/ISO projects that are titled 80601 series too.  So, keep your eyes and ears peeled and open to keep up with what will be happening soon.

So, what is Annex ZA about?

Annex ZA is a listing of normative (required or mandated) references to international publications with their corresponding European publications.  This is a list of the European & EU Harmonized standards.  This primarily changes most of the IEC and ISO standards that are referenced in IEC 60601-1:06 + A1:13 (ed. 3.1) to EN & EN ISO standards for the EN version of the standard.  The standards that change in the base of the standard are marked by (mod.) to indicate the original requirements have been modified by common modifications as noted in the beginning of Annex ZA.  There are some that stay as IEC & ISO standards but most change.  But that isn’t the bombshell.  When A1:12 of IEC 60601-1:05 was published a decision was made to go from dated references for the IEC 60601 series standards (i.e. IEC 60601-1-2:2007) to primarily undated references (IEC 60601-1-2), unless a specific standard reference didn’t meet the criteria for the change (most changes occurred and a few stayed as dated references).  The primary reason for this change was to make the standards development maintenance process of the whole series of standards (almost 60 standards in the series & growing) easier to update when there was a change in a Particular (i.e. IEC 60601-2-XX) or a Collateral standard (i.e. IEC 60601-1-XX).  About a year ago under the IEC A1 version of 60601-1 undated references came about but that now has been changed back to dated references in the EN version of the standard (EN60601-1:06 +A1:13).  This means, as it says at the beginning of Annex ZA, “For dated references, only the (dated) edition cited applies.”  Annex ZA also says “For undated references, the latest edition of the referenced document (including any amendments) applies.”

So, for the IEC series of 60601 standards you currently have the Collaterals and Particulars being updated or will be updated in the near future (now thru about 2 years from now) to reflect the undated standards references to filter through-out the whole series of IEC 60601 standards.  So, more change to keep an eye out for.  Some people would say you need to have a Master’s degree to keep up with this but you could rely on consultants, like me, as this is one of my many job duties is to keep up-to-date on standards development information so I can keep my client’s informed & up-to-date.

And what about Annex ZZ?

Annex ZZ is a fairly long section clocking in at 19 pages long and part of the focus is on the Risk Management Process of sub-clause 4.2.2 of EN 60601-1:06 + A1:13 as the EN ISO 14971:2012 standard is the Harmonized standard most recently called out in the EU MDD Harmonized List of Standards (a voluntary listing but easiest way to prove compliance too) and is a significant modification of ISO 14971:2007 with some major changes to it.  So read on for more details with respect to the changes for risk management, among other issues for this Annex ZZ.

Annex ZZ is titled the “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices”. Annex ZZ is a means for showing conformance to meeting the parts of the Essential Requirements (ER’s), Annex I, of the MDD under 93/42/EEC as amended by 2007/47/EC, that apply to the standard EN 60601-1:06 + A1:13.  This standard doesn’t confer compliance with all of the ER’s under the MDD only certain ER’s in whole or in part.  I am repeating the first page text of Annex ZZ in “quotes” below and then writing my commentary, in italics, to explain each section.

“This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association to provide a means of conforming to the Essential Requirements given in Annex I of the EC Directives 93/42/EEC as amended by 2007/47/EC.”

This means that EN 60601-1:06 + A1:13 Annex ZZ will be the means to prove conformance to the ER’s of the MDD in whole or part based on a mandate to CENELEC from the European Commission & EFTA.

“Once this standard will be cited in the Official Journal of the European Union under that Directive, compliance with the clauses of this standard given in Table ZZ.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements (ERs) of that Directive and associated EFTA regulations.”

Once this standard is Harmonized under the MDD (via publication thru the OJEU) compliance with the clauses of the standard, within the limits of the scope of the standard, cited in Table ZZ.1 confers a presumption of conformity with the corresponding ER’s of the MDD & associated EFTA regulations (MDD adopted by EFTA). 

 “NOTE 1     This standard is intended to be applied in its entirety only. Selected clauses or subclauses may be not applicable due to the specific type of equipment under consideration. It is necessary to understand and apply Clauses 1 to 5. It is also recommended to understand and apply those clauses which contain general requirements related to a specific subclause. Elements of the standard that are not cited in Table ZZ.1 may be relevant for the appropriate fulfilment of certain essential requirements through indirect reference, and for safety and performance aspects of the device, that are not addressed through essential requirements.”

You must use the whole standard.  You can’t just pick and choose clauses you need the whole enchilada otherwise not a valid evaluation of the product.  But you may be able to cite & provide justification that certain clauses & sub-clauses don’t apply to your specific device.  Clauses 1 thru 5 of the standard must be applied and understood completely and well.  These clauses include the scope of the standard, the object, how the Particular and Collateral standards of the 60601 series of standards apply, which standards are normative references and how they work (dated vs undated), terminology & definitions, general requirements which includes discussion of & requirements for:

• Conditions of the equipment to be tested and analyzed
• The Risk Management Process
• Essential Performance
• Expected Service Life
• Equivalent Safety
• Parts that touch the Patient but aren’t to be marked as Applied Parts
• Single Fault Condition
• Component requirements
• Use of High-Integrity Components
• Power Supply issues

And General Requirements for Testing the ME Equipment

• Type Tests
• Number of Samples for testing
• Environmental issues
• Test conditions
• Repairs and modifications
• Humidity preconditioning
• Sequence of tests
• Determination of Applied Parts vs Accessible Parts

 Also, all clauses that apply general requirements related to specific sub-clauses must be considered & addressed.  Even if there are specific sub-clauses that aren’t cited in the Table ZZ.1 that doesn’t mean they aren’t valid to help meet some of the ER’s even if indirectly & for safety & performance aspects of the device, not addressed through the ER’s.

“NOTE 2     Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance to the MDD (Directive 93/42/EEC amended by 2007/47/EC). This means that risks have to be reduced “as far as possible”, “to a minimum”, “to the lowest possible level”, “minimized” or “removed”, according to the wording of the corresponding essential requirement.”

Where there is a reference made from a clause of the standard EN 60601-1:06 + A1:13 to the risk management process, the risk management process needs to be in compliance with the MDD.  This means that risks have to be reduced according to the specific wording of the corresponding ER.  Such as with the wording “as far as possible”, “to a minimum”, etc.

“NOTE 3     With respect to note 4 of clause 4.2.2 General requirement for risk management, the manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the directive.”

Note 4 of clause 4.2.2 “General requirement for risk management” states:

“NOTE 4     Where requirements of this standard refer to freedom from unacceptable RISK, acceptability or unacceptability of this RISK is determined by the MANUFACTURER in accordance with the MANUFACTURER’S policy for determining acceptable RISK.” 

This infers that the standard IEC 60601-1:05 + A1:12 requires that Risk is determined by the Manufacturer’s policy for determining acceptable risk which is the Risk Management Process under ISO 14971:2007 per the IEC standard (ed. 3.1) but once you get into the MDD & EN Harmonized standard it will be EN ISO 14971:2012 based on the conversion done in Annex ZA.

So, continuing on — Risk is determined by the Manufacturer’s policy for determining acceptable risk which is the Risk Management Process under EN ISO 14971:2012 for the ER’s 1, 2, 5, 6, 7, 8, 9, 11 & 12 of the MDD.  When you look at Table ZZ.1 you will see in a greyed out area of the top of each ER section for ER’s 1, 2, 5, 6, 7, 8, 9, 11 & 12 there is a note that says “General Guidance note 2 and 3 shall be observed” which infers that you need to follow the risk management process stated in these specific ER’s per EN ISO 14971:2012 Annex ZA (for the MDD) which is where all the modifications of the Risk Management standard were made by the EU Commission causing total havoc for the EN ISO version of the standard even though not in the main text of the standard Annex ZA has caused a total mess of what was once a specific standard and now has been jumbled and makes it hard to meet risk management requirements for multiple countries when one of them is the EU and there are other countries involved as ISO 14971 & EN ISO 14971 are in direct conflict with each other.  You can meet one but not both at the same time from what I have surmised.

“NOTE 4     References in the clauses 3 to 17 or in the Annexes of this standard specify whether the normative references listed in Clause 2 as cited in Annex ZA are to be applied in whole or in part.”

Clauses 3 to 17 (the meat of the standard) and the Annexes of the standard EN 60601-1:06 + A1:13 specify whether the mandatory (normative) references listed in Clause 2 (the clause for all the Normative References of the standard), which in the EN version of the standard is replaced by the citations in Annex ZA for clause 2, are to be applied in whole (the whole standard) or in part (a certain portion of the standard) as noted in the standard itself.  

“NOTE 5     This Annex ZZ is based on Normative References according to Annex ZA, replacing the references in the core text.”

Annex ZZ of this EN 60601-1:06 + A1:13 standard is based on the Normative references of Annex ZA (Normative Standards that were replaced from IEC & ISO standards to the European EN, EN ISO, & HD standards in the EN 60601-1:06 + A1:13 version of the standard).  Bottom line this means that all the IEC 60601-1:05 + A1:12 normative references are to be replaced by the Annex ZA normative standards references for the EN 60601-1:06 + A1:13 version of the standard.

“WARNING: Other requirements and other EU Directives and Regulations may be applicable to the product(s) falling within the scope of this standard.”

This simply means that the MDD is not the only Directive that may apply.  Some examples of Directives and Regulations that may apply include the following examples:

• Restriction of Hazardous Substances (RoHS2) Directive 
• This is coming up for most medical device manufacturers in June of 2014.  That’s not a lot of time to get ready for this process.  If you would like to learn more about this process for the medical device manufacturer please join me in a presentation on RoHS2 for the Medical Device Industry on 17 Dec 2013.
• Waste of Electrical and Electronic Equipment (WEEE) Directive
• Machinery Directive
• Radio and Telecommunications Terminal Equipment (R&TTE) Directive
• Privacy / data protection Clinical data and other personal data Directive
• Regulation on electronic instructions for use of medical devices
• Etc.

Note, that Axon Lawyers has prepared a document for their local RAPS group on the associated Directives that may apply to your EU medical devices and they have been generous to allow all of us to have access to it.  So, thank you Erik Vollebregt for one of your many resources that has helped my clients and I to understand better the implication of the Warning in Annex ZZ of EN 60601-1:06 + A1:13. 

So, get a copy of the standard EN 60601-1:06 + A1:13 so you can have access to the important Annex ZA and Annex ZZ.   If you follow the details noted there you should be in good shape. Annex ZZ is a useful tool to make it easier to know what ERs are applicable to the 60601-1 standard and what is expected instead of doing it blindly for so many years without that support. Last week I actually used this table in Annex ZZ very successfully to audit a MDD Technical Files ER checklist and it provided a wealth of information that just made my life a lot easier and will make yours a lot easier too if you need to put an ER Checklist together for your next Technical File or for a Design Dossier too.

I remember when first working on the IEC based standard that I am a convener of (IEC/ISO 80601-2-58) I was requested to work on the parallel EN standard.  Someone in our Joint Working Group (JWG) suggested that we (the JWG) put together an Annex ZZ but I was later told by some in Europe the 60601 series of standards wasn’t doing that yet because of some political issues that I was never clear on. So, I guess we finally broke that cycle, many years later, and now many of the 60601 series of standards are slated to go thru this process (41 thru the end of 1^st quarter of 2014). I think at first probably the more popular ones will get processed and who knows how long it will take to get all of them processed thru.

If your company needs help with edition 3.0 or 3.1 for EN or IEC 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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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)