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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What’s it about:  Are you ready for implementation of the EU RoHS2 Directive 2011/65/EU (Restriction of Hazardous Substances – recast)? If not, you may need to stop shipment of your medical devices to the EU. The RoHS2 Directive has been implemented and the transition period has officially passed. The medical device industry is one of several industries with a small reprieve, but that time frame is running out quickly and there is less than a year to prepare. In July of 2014 you will need to ensure that your medical electrical & electronic equipment (EEE) devices meet the RoHS2 Directive.

This Directive doesn’t just impact the manufacturer but also the importers and distributors as well. Join us to find out more about the impact on the medical device industry, as our speaker guides attendees through the key parts of this Directive, including the scope, definitions, timelines, exemptions, roles & responsibilities for manufacturers, importers & distributors, technical documentation requirements, assessment of conformity with the Directive, record retention, Authorized Representative requirements, and much more.

This audio conference will cover:

• EU RoHS2: scope, definitions and exemptions for the medical device industry
• Compliance requirements for manufacturers, importers and distributors
• Requirements for technical documentation, Declaration of Conformance, record retention, marking, affixing the CE Mark, and Authorized Representative
• Conformity Assessment of the product with the Directive
• Market surveillance for RoHS2 Directive
• Recalled products requirements and corrective action to be taken
• Notification to national authorities and supply chain of non-compliant product
• COCIR requested product exemptions
• Resources and tools to help along the way

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 recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011/65/EU.  You can read the directive at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF.  With the exception of the items listed in Article 2.4, the RoHS Directive applies to all Electrical & Electronic Equipment.

As an overview:

–   Scope:

• • Medical devices (per 93/42/EEC) and IVD devices (per 90/385/EEC) are now included.  They are both part of the general group called “medical devices” in the directive.
  • Active implantable medical devices remain excluded from the requirements of the directive.

–   Limits: The maximum concentrations in homogenous materials are limited, by weight:

• • Lead (0.1 %)
  • Mercury (0.1 %)
  • Cadmium (0.01 %)
  • Hexavalent chromium (0.1 %)
  • Polybrominated biphenyls (PBB) (0.1 %)
  • Polybrominated diphenyl ethers (PBDE) (0.1 %)

–   Transition: Devices must bear a CE mark and have a declaration of conformity for the RoHS Directive from

• • 22 July 2014 for Medical Devices.
  • 22 July 2016 for In-Vitro Diagnostic Medical Devices.

NOTE:  A single CE mark and declaration are acceptable.  (You will need to explain the dual meaning of the CE mark in the instructions for use and clarify that, if used, the Notified Body number only applies to the MDD or IVDD related issues.)

–   Exemptions:

• • Cables and spare parts needed for the repair or reuse of devices may continue to be distributed for devices placed on the market prior to the transition date.
  • Exemptions available to all devices are listed in Annex III.  Specific exemptions for medical devices are listed in Annex IV.
  • Exemptions for medical devices will be valid for up to 7 years.
  • Requests for exemptions:

• • • Will be filed with the Commission and include all information listed in Annex V.  Most notably, the request must include an analysis of possible alternative substances, materials or designs.
    • Renewals must be requested at least 18 months before the existing exemption expires.
    • Applications for exemptions will be accepted for medical devices even before the RoHS Directive is fully transposed (2JAN2013) if an overseeing Notified Body certifies that the safety of potential substitute has a clear negative socioeconomic, health and consumer safety impacts.

–   Labeling: The labeling requirements are likely already addressed by MDD or IVDD requirements.  However, you should review the requirements in Articles 7.g, 7.h9.d and 10.a to confirm.

–   Record Retention:

• • Records must be retained for 10 years after a device is placed on the market.  Note that this may be longer than required by the MDD or IVDD.
  • Records to retain include:
    • Technical documentation confirming compliance with the RoHS Directive and a register of non-conforming product and product recalls,
    • List of any economic operator (manufacturer, authorized representative, importer, distributor) who has supplied you with electrical or electronic equipment, and
    • List of  any economic operator to whom you have supplied any electrical or electronic equipment.

If you would like to see some additional information on some of the areas, in the future, that may be implemented refer to the  BSI article that is posted on our website.

Our group (Eisner Safety Consultants) has worked with a select set of service providers that can obtain the CofC’s or the total composition information for each component and in turn the full product composition.  Please feel free to contact me, Leo Eisner (Leo@Eisnersafety.com) if you have any questions on this subject and I would be more than happy to assist you.

Please contact us if you have questions or concerns.

Medical device manufacturers should be aware that it is not only the medical devices directives that are currently being considered for a recast; also other parts of EU legislation are being revised. One of these is the RoHS Directive that regulates hazardous substances in electrical and electronic equipment (EEE) in the EU. Work on the revision started in 2008 when it was called RoHS 2 (or RoHS II). By now the revision is ready and will be presented as “RoHS Recast,” because the existing directive will be repealed and replaced rather than simply amended.

Utilizing the EU’s New Approach and New Legislative Framework, the new directive will move specification of restricted substances and covered EEE to the Annexes so that they can be easily “adapted to technical progress” (ATP). The CE mark will be required for compliance; procedures for conformity assessment are specified; and standards developed by European Standards Organizations are utilized.  The European Parliament adopted the “consolidated text” for RoHS Recast late 2010, and the final step to approve legislation in the Council of the European Union is very near.

The change will significantly impact the medical device field. Where currently all medical devices and IVDs are exempt from the directive, the automatic exclusion from RoHS will disappear for MDD and IVDD devices, while it remains in place for active implants under AIMDD. The new legislation has foreseen various transition times. Medical devices, as well as monitoring and control instruments, must comply within three years after publication in the EU Official Journal, whereas IVDs must comply within five years.

The six original RoHS substances (lead, mercury, cadmium, hexavalent chromium, PBB and PBDE as identified in RoHS Annex II) are still the only ones restricted, and no changes were made to their allowed concentrations.  However, future additions to the list remain likely. The Environmental Committee report recommended that brominated flame retardants, chlorinated flame retardants, PVC, chlorinated plasticizers, DEHP, BBP, and DBP be restricted. The COR Committee opinion expressed regret that HBCDD, DEHP, BBP, and DBP were not included. Moreover, a full evaluation of the new Annex II, specifying the banned substances, is required in three years.

It is possible for individual manufacturers to apply for specific exemptions. (Specific procedures have been set up to grant the information; annex V or RoHS recast provides details.)  A list of exemptions granted for 7 years exists. The application needs to be submitted before 2014, realizing that the renewal to exemptions has to be sent 18 months before the deadline.

If no exemption is successfully obtained, then to comply with the Directive the manufacturer will need to set up a self-declaration of conformity referring to the RoHS. In order to do so, manufacturers must maintain technical documentation, cite relevant harmonized standards, implement internal production controls, and keep a register of nonconforming products. CE mark is required on the finished product, as well as manufacturer’s name, trademark, contact address, and a type, batch or serial number (to facilitate recalls) should be present on the labelling.  The EC Declaration of Conformity (specified in annex VI) that accompanies the finished product should be in the language of the local market. In the event that the product is manufactured outside the EU, then the EU importer who will share the responsibility for compliance with the manufacturer is also needed.

The EU Commission website to monitor for news of the recast of RoHS Directive is:http://ec.europa.eu/environment/waste/weee/index_en.htm

Our group (Eisner Safety Consultants) has worked with a select set of service providers that can obtain the CofC’s or the total composition information for each component and in turn the full product composition.  Please feel free to contact me, Leo Eisner (Leo@Eisnersafety.com) if you have any questions on this subject and I would be more than happy to assist you.