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.

Standards are a key priority for the International Medical Device Regulators Forum (IMDRF).

Its forthcoming guidance, “Optimizing Standards for Regulatory Use,” encourages the development of ‘regulatory ready’ standards, including direction to Standards Development Organizations (SDOs) to consider medical device ‘essential principles’ when writing standards.

This webinar will introduce viewers to IMDRF, review this upcoming guidance, and discuss the role IMDRF and its priorities play in relation to international medical electrical equipment standards in the IEC 60601 series (IEC 60601-X-YY / IEC/ISO 80601-2-YY), proposed IEC 60601 series updates, and significant changes planned for the draft IEC 60601-1 Ed3.2.

Finally, it will summarize why standards conformity assessment is critical to ensure success of global harmonization.

This webinar is being co-presented by me, Leo Eisner, the “IEC 60601 Guy”, founder and principal regulatory & product safety consultant at Eisner Safety Consultants, along with Captain Scott Colburn and Gail Rodriguez of the FDA, and moderated by Jon Speer of Greenlight Guru.

WHEN: November 1, 2018 1PM ET/10AM PT

Sign-up now for the limited live seating of the free webinar

Top Take Aways

• Overview of IMDRF
• IMDRF’s forthcoming guidance “Optimizing Standards for Regulatory Use”
• Key concept of the Essential Principles of Safety & Performance
• Concept of Essential Performance in IEC 60601 standards for medical electrical equipment and how it relates to the Essential Principles
• Upcoming major changes and revisions to the IEC 60601 series

Who Should Attend?

• Medical Device Industry Executives
• Regulatory Affairs Professionals and Management
• Quality Professionals and Management
• Clinical Affairs Professionals and Management
• R&D Engineers and Management
• Regulators
• Standards Development Organizations and Standards Developers
• Test Labs
• Accreditors

IMDRF History & Further Details About Webinar

The International Medical Device Regulators Forum (IMDRF) was established in February 2011 as a forum for a voluntary group of medical device regulators from around the world to promote medical device regulatory harmonization. Standards, as an important resource for harmonization, are a key priority for IMDRF. The draft IMDRF guidance “Optimizing Standards for Regulatory Use” is primarily directed at regulatory authorities (RAs), Standards Development Organizations (SDOs) and those interested in the application of standards to support regulatory frameworks (i.e. manufacturers), the guidance aims to encourage the development of ‘regulatory ready’ standards, including direction to SDOs to consider medical device ‘essential principles’ when writing standards. Essential principles, which are outlined in ISO 16142 and currently under development at IMDRF, will include references to medical device performance.

The IEC 60601 series of standards for medical electrical equipment and systems also feature expectations for essential performance. We will highlight the intersection of the two key concepts between the essential principles and the IEC essential performance to demonstrate how standards can help with global harmonization in medical device regulation.

Further, we will provide a brief update on the latest standards revision status for the IEC 60601 series, including some significant changes planned for the draft IEC 60601-1 Ed3.2.

About Leo Eisner

Leo is heavily involved in the IEC 60601 standards development process for several of the standards in the series. He is the US Co-chair for IEC SC62D in charge of a majority of the IEC 60601-2-XX / IEC/ISO 80601-2-XX Particular Standards. He is on several Working Groups and Maintenance Teams working on the development of the draft IEC 60601-1, edition 3.2 (3rd edition + Amendment 2).

Eisner Safety Consultants has helped countless clients thru the Regulatory and Product Safety maze over our 22 year history of the company. Leo has over 30 years experience in product safety and 24 years experience in the medical device industry. Leo ran the Compliance Engineering Group at Karl Storz and was a Senior Product Safety engineer at TÜV Product Service prior to starting Eisner Safety Consultants. Leo has worked as a Notified Body auditor and technical reviewer for TÜV Product Service/SÜD, NSAI, and is currently a technical reviewer for Pre-Safe (Joint venture between NEMKO & DNV).

About greenlight guru

greenlight.guru is the only Quality Management Software built exclusively for the unique needs of medical device companies, allowing you to bring safer devices to market faster while reducing risk and ensuring compliance. Visit their home page to learn more.

About Eisner Safety Consultants

Leo is heavily involved in the IEC 60601 standards development process for several of the standards in the series. He is the US Co-chair for IEC SC62D in charge of a majority of the IEC 60601-2-XX / IEC/ISO 80601-2-XX Particular Standards. He is on several Working Groups and Maintenance Teams working on the development of the draft IEC 60601-1, edition 3.2 (3rd edition + Amendment 2).

Eisner Safety Consultants has helped countless clients thru the Regulatory and Product Safety maze over our 22 year history of the company. Leo has over 30 years experience in product safety and 24 years experience in the medical device industry. Leo ran the Compliance Engineering Group at Karl Storz and was a Senior Product Safety engineer at TÜV Product Service prior to starting Eisner Safety Consultants. Leo has worked as a Notified Body auditor and technical reviewer for TÜV Product Service/SÜD, NSAI, and is currently a technical reviewer for Pre-Safe (Joint venture between NEMKO & DNV). We provide assistance with U.S., Canadian, European, & other international regulations. Learn more about our services we offer.

ABOUT FDA CDRH
In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. We assure that patients and have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

We seek to continually improve our effectiveness in fulfilling our mission by planning strategically and regularly monitoring our progress.

• Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices : Final Guidance

Podcast on Standards & FDA’s Release of these Guidance Documents

FDA’s Captain Scott Colburn and Leo Eisner of Eisner Safety Consultants did a podcast with Jon Speer of Greenlight Guru on Standards Development of the IEC 60601 Series and these recently released Guidance documents. Listen to this conversation…

Some of items of note with the Final FDA Guidance include:

• FDA can now Recognize a standard and place on the Recognized Consensus Standards db prior to a formal Federal Register updates
• Declaration of Conformity (DOC) to follow requirements of ISO 17050-1 or as specified in the Final Guidance in section IV. A. (1)
• DOC process different for Consensus Standards that are horizontal, process-oriented, or that include choices relating to test methods, test selection, or have guidelines that apply to a broad range of device types and safety issues then FDA recommends submitters follow ISO 17050-2 – Supplier’s DOC – Supporting Documentation per section IV. A. (2) of the Final Guidance

IEC 60601-1, edition 3.2 (draft) and it’s collateral standards (IEC 60601-1-XX) are being updated and Leo discusses why this is happening, the timing and some of the impacts on manufacturers and design houses in this podcast.

FDA Guidance Documents – Additional Information

The draft guidance will be open for public comments and suggestions for 60 days at https://www.regulations.gov under Docket Number: FDA-2018-D-2936.

The Appropriate Use of Voluntary Consensus Standards final guidance describes the appropriate use and documentation of consensus standards for premarket submissions and how FDA staff intends to rely on consensus standards during the review process. Appropriate use of voluntary consensus standards can reduce requests from FDA staff for additional information to address issue(s) the standard was intended to address.  This guidance provides further clarity and explanation about the regulatory framework, policies, and practices regarding the appropriate utilization of consensus standards for premarket submissions.:”

Webinar about the Appropriate Use Final Guidance:

FDA will be hosting a Webinar on Thursday, October 25th, 2018. The webinar will be for manufacturers & others interested in learning more about the Appropriate Use final guidance. No registration is required.

• Time: 1:00 – 2:00pm EST (To ensure you are connected, dial-in prior to the start of the webinar)
• To hear the presentation and ask questions:
  Dial: 800-475-0481, International Callers Dial: 1-517-308-9467; Conference Number: 8090070; Passcode: 2387655
• To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW8090070&p=2387655&t=c
• Following the webinar, a transcript, audio recording, and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

Need help sorting out the proper medical device standards that apply to your device submission for the US, Canada, EU or elsewhere? Contact Leo “the IEC 60601 Guy” Eisner to help you thru this process at Leo at EisnerSafety dot com or schedule a call with Leo.

View all the articles I have written for InCompliance Magazine.

I hope you enjoy this article and if you have any questions please feel free to contact me at Leo at EisnerSafety dot com or schedule a call with me.

Leo Eisner, the “IEC 60601 Guy” & Principal Consultant, of Eisner Safety Consultants attended several IEC SC 62A Maintenance Team (MT 28 & MT 30) and Working Group (WG14) meetings from March 22 – March 31, 2017 in Oslo, Norway and London, United Kingdom to start the work of reviewing the items agreed on (in Frankfurt Oct 2016) for IEC 60601-1, 3rd ed. + Amendment 2 (or ed. 3.2) for development and comment.

A2 of IEC 60601-1 & its’ related collateral standards are anticipated to be published by the end of 2019.  In only 2+ short years from now!!!!  Will you be ready?  We are offering a web special til the end of March May 2017 on our Annual Standards Trends Reports.  See more below.

A2 changes & collaterals changes may include any of the following:

• safety gaps needing corrections,
• known problems for regulatory bodies,
•  inconsistencies within the standard,
• technical errors, and
• updates of standard references.

The above was the criteria for the ‘Short List’ vote on which items were agreed to in Frankfurt (Oct ’16) for A2 for IEC 60601-1 and it’s collateral standards.

Also, you need to be aware that the items that didn’t make it to the ‘short list’ are slated to be worked on for the 4th edition of IEC 60601-1 (the ‘long list’) which is scheduled to be published in 2024.  This will be a much more significant set of changes including potentially restructuring the standard and maybe even making the whole series a database standard.

Are you ready for changes coming for 60601-1, 3rd edition + Amendment 2 and 4th edition of IEC 60601-1?

We can help you stay up to date and ahead of the curve so you are prepared for these changes that are coming.  Check out our Annual Standards Trends Report as a fantastic resource that can save your company significant time and money (upwards of $100,000+).

To provide you an opportunity to receive the Eisner Safety Consultants Annual Standards Trends Reports for a significant discount of this year’s copy of these reports (publication between Late May to June 2017) we are offering a web special til the end of March May 2017 to give you the opportunity to learn from Leo about the Amendment 2 meetings in Oslo, Norway and London, U.K. The reports will include more details where these Amendment 2 changes are at and what these changes are.  If you want to stay ahead of your competitors, and save on the cost of standards committee membership fees, save on travel expenses, save time instead of sitting in these meetings, and getting the benefit of staying up to date on medical electrical equipment & systems (MEE&S) standards and home use MEE&S standard consider this amazing deal:

Eisner Safety Consultants

Annual Standards Trends Reports on MEE&S &

Home Use MEE&S Options

Get This Year’s Report(s): May/June 2017 Annual Standards Trends Report (ASTR) Options:

Normally priced at $1,997.00 Web Special $1,597.00 for the:

May/June 2017 Medical Electrical Equipment & Systems (MEE&S) ASTR OR

May/June 2017 Home Use MEE&S ASTR

Normally priced at $2,997.00 Web Special $2,497.00 for the:

Bundle pricing of both the May/June 2017 MEES & Home Use MEE&S ASTRs

Get This & Last Year’s Report(s): March 2016* & May/June 2017 ASTRs Options:

Normally priced at $2,397.00 Web Special $1,997.00 for the:

March 2016* & May/June 2017 Medical Electrical Equipment & Systems (MEE&S) ASTRs OR

March 2016* & May/June 2017 Home Use MEE&S ASTRs

Normally priced at $3,697.00 Web Special $2,997.00 for the:

Bundle pricing for all 4 Reports – March 2016* & May/June 2017 of both MEE&S & Home Use MEE&S ASTRs

* = MAR ‘16 ASTRs issued as of MAR ‘16 with no updates for these ridiculously low rates.

If you need help with IEC 60601-1 please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants and considered the ‘IEC 60601 Guy’ by many of his clients and associates.

(Note this service is not offered anymore please contact us with your questions.)

Do you make Medical Electrical Equipment & Systems (MEE&S) or Home Use MEE&S? Are you up to date on all the applicable Current & Draft Medical Electrical Equipment Standards, Technical Reports, etc?

Do you have the resources to do this efficiently and with minimal cost & time?

1. Are you able to have one or more employees from your company sit in all the standards developing meetings to write the standards?
2. Can you afford the high fees of being on the National Committees?

If not, consider an Industry Leader’s specialized Annual Reports on Medical Electrical Equipment & Systems (MEE&S) Standards or on Home Use MEE&S Standards. Leo Eisner has over 20 years experience in the medical electrical equipment product safety industry with standards development as one of his primary focuses for over 12 years and he is on many of the standards committees that develop the standards in these reports both on the MEE&S and Home Use MEE&S markets.

What are the implications if you don’t stay up to date on these critical documents?

1. You may need to redesign your product before submitting to a regulatory agency for review and approval,
2. Your Notified Body Auditor or your Quality System Certifier may issue a Non-Conformance for not being up to date on the applicable standards and technical reports that apply to your products.
3. Your regulatory strategy for your products lines may be out of date which could delay your products getting to market on time.
4. And more….

If you’re a medical device company that makes any type of electrical equipment you will want one or both of these reports as there are a lot new standards, Technical Reports and related documents recently released and also being developed that you should be on top of. Many Medical Device Companies don’t have the resources (time & money) to afford to have someone sit in the standards meetings, commit to the time to support the committee work to write the standards, and pay the high fees needed to be a national committee member of ANSI, AAMI and other standards developing organizations. That’s why many in the medical device industry rely on Leo Eisner of Eisner Safety Consultants to provide them with detailed reports on what is happening with all these changes.

If you want to stay up with the currently and in process medical electrical equipment and system (MEE&S) standards and home use MEE&S standards and technical reports before they are published or while in development to help with their regulatory strategy it is always helpful to know what is coming up in the near to long term. Also, it is good to know what has been published too as new titles don’t always get into standard update services clients get from standards sales houses because those are not being monitored yet.

These reports are based on the Annual Standards Committee Meetings plus all Leo’s standard committee involvement.  Leo was at the Kobe meeting in Japan Nov 2015 and this report covers what are the future plans for many of those Standards & Technical Reports including:

1) IEC 60601 series of standards on Electrical Medical Equipment and Systems (status update on changes in process),

2) Draft IEC/TR 60601-4-2  Electromagnetic immunity Guidance & interpretations,

3) IEC/TR 60601-4-3 interpretations of IEC 60601-1, Ed. 3.0 & 3.1 (I am on this Working Group),

4) Draft IEC 62366-2 Guidance on the application of usability,

5) IEC/ISO /TR 80001-X-Y series on Application of risk management for IT-networks incorporating medical devices,

6) Draft IEC 82304-1, ed. 1.0 Health software – Part 1: General requirements for product safety,

7) IEC 62304, Ed. 2.0 – Software Lifecycle Process,

8) Draft IEC/TR 60601-4-1 Guidance and interpretation – Medical electrical equipment and medical electrical systems employing a degree of autonomy,

9) Draft IEC/TR 60601-4-4 Guidance for writers of particular standards on creating alarm system related requirements (Not even on the official IEC Work Program as of March 15, 2016 but being on these committees I get a birds eye view of what is going on and I have direct links with lots of the committees I am not directly on as well),

10) US Version of IEC 60601-1-11 on home healthcare environment for Medical Electrical Equipment and Systems,

11) Draft of US Version of IEC 60601-1-12 on Emergency medical services environment for Medical Electrical Equipment and Systems,

12) Draft AAMI TIR75, Factors to Consider When Multi-Vendor Devices Interact Via an Electronic Interface, (Proposed new Technical Information Report),

13) IEC 62366-1, Edition 1.0 Medical devices – Part 1: Application of usability engineering to medical devices, and how FDA is dealing with this and the older version of the standard,

14) etc…

Other area of Interest in the report include:

1) Some regulatory impacts of some of the standards in the report like what is FDA expecting on IEC 60601-1-2:2014 (4th ed vs 3rd ed)

2) Harmonization roadblock issues for the EN 60601 series and how best approach it.

This should give you a flavor of the reports.  I also provide listings of the TC62, SC62A & 62D (some 62B & 62C) Committees for Electrical Medical Devices for IEC & EN standards & technical reports that have been issued in the last year or so and drafts of EN standards close to publication (not Harmonized just EN).

For the Home Use Report I have 13 pages of information on the Committees that focus on Home Use for the US and also for IEC (new Systems Committee for Active Assisted Living) plus lot of additional information.

These reports will be ready for release by the end of March or early April 2016. Cost $3,500* (US$) per report or for both of them just $6,500** (US$).  This is steal compared the time I socked into each one of these reports, the meetings I sat in on for 2 weeks in Nov in Japan (Kobe & Tokyo) in Nov 2015, and also the money saved not having to be on the committees, the travel expenses for getting to the meetings,  the time in the meetings, and the expected contribution to the standards development for being in these committees.  That is a lot of man hours that you get inexpensively from my hard work.

Contact us to purchase a copy of these reports now. Leo@EisnerSafety.com or call us at 503-244-6151.

* Current & past Eisner Safety Consultants Clients are eligible for a bigger discount if you purchase one of the reports.  To see the current discount go to the specialized services webpage for more details and for payment terms.  Please contact us to arrange for this special discount.

** Current & past Eisner Safety Consultants Clients are eligible for a bigger discount if you purchase both of the reports.  To see the current discount go to the specialized services webpage for more details and for payment terms.  Please contact us to arrange for this special discount.

This blog discusses the following points:

• Definition of APPLIED PART
• Examples of APPLIED PARTS for specific medical devices
• Examples of different types of APPLIED PARTS (Type B, BF, CF or & each can be Defibrillator Proof for a total of 6 APPLIED PARTS classifications)
• 3 Notes in regard to the Definition of APPLIED PART

Introduction of IEC 60601-1 (third edition) with amendments

They will be requiring that for electrical medical devices these products will need to meet IEC 60601-1, 3^rd ed. (2005) + Amendments*.   This requirement is effective for Class 3 & 4 medical devices as of June 1 2014, for Class 2 medical devices as of June 1 2015 and lastly for Class 1 medical devices as of June 1 2016.

* Depending on what this Amendment to the Medical Devices Act consider Amendments it could be just Amendments of the standard or it could include & probably should consider the Corrigendums and Interpretation Sheets too.   All the possible current Amendments are Amendment 1:2012 + Corrigendums 1:2006 and 2:2007 for 3^rd ed. and Corrigendum 1:2012 for ed. 3.1 + Interpretation Sheets 1:2008, 2:2009, & 3:2013.

The notice also states that MFDS will lay down new safety standards for software as medical electrical equipments.  My guess is that they will require complying with IEC 62304 which is the standard for Medical Device Software Lifecycles as it has become very popular around the world for many national regulatory bodies.  We will have to wait and see what happens for this requirement, as the notice is not clear as to what standard(s) they will use as of now.

Introduction of the Summary Technical Documentation (STED)

As of January 1 2014 Class 4 medical device applicants (except for IVD reagents) will be required to submit in the the STED format.  MFDS says that this will expedite the review timelines for the manufacturers and devices that are submitted.  Class 1, 2, & 3 devices have the option of submitting in the STED format as of the date for the notification.

Revised “Regulations on Classification and Grades”

MFDS announced several changes for the regulations on classification and grades covering the following issues:

• 94 new products are added under “cell manipulating kit for medical use”.
• Definitions for 108 products have changed including for “heater systems”.
• The Class of “dental color measuring devices” was down-classified to Class 1.
• 67 commercial names including “warm bath equipment” are edited out.
• The changes are effective as of the date of notification.

On October 1, 2011 the DRAFT “FAQ related to Implementation of EN 60601-1:2006 Clarification of open issues” was issued and this DRAFT document is being sent to NB-MED for commenting on the document.  NB-MED is also known as TEAM NB.  This organization is the European Association of Notified Bodies for Medical Devices which covers the MDD (93/42/EEC), AIMDD (90/385/EEC), and IVDD (98/79/EC).  This group publishes guidances that are agreed on by the Medical Device Directives (93/42/EEC, 90/385/EEC, and 98/79/EC) Notified Bodies. Once all the responses are agreed to it is anticipated that the document will be released as an NB-MED guidance document.

The History of this DRAFT document is restated below.  Note that any “click here” links are not live in the below text but are live in the actual DRAFT document.

History

During spring 2011, it was realized that the use of EN 60601-1 and its many family members in demonstrating compliance with the relevant and applicable requirements of the European medical device regulatory framework was not too trivial. While relevant guidance on the matter had been published at the CENELEC website as a Q&A document (click here), some Notified Bodies were giving advice that was felt to be not in line with that guidance. On other occasions, questions were raised that were not covered in the guidance.

So, it was concluded that the situation for electrical equipment in medical practice was not totally clear and that additional guidance would be useful. Further contact with the chair of the NB-MED confirmed this desirability, and a small group of experts was established. This group developed an enquiry asking for “practical issues in the implementation”, that was sent to many stakeholders in June 2011(see Annex 1). Also at the international level of IEC the request was distributed (62A/769/INF).

The response to the request was beyond expectation and the small team of experts, initially consisting of three, was expanded with Dr. Klaus Neuder of DKE (Frankfurt, Germany).

End of July 2011, the work on digesting the issues submitted until then started and it took until end of September 2011 until all material had been thoroughly discussed and answers formulated to the questions that were raised. In some cases, the questions were slightly amended to make them a little more general, and a few additional “connecting” questions were developed by the team.

It is believed that the answers, developed in close team cooperation, present a fair response to the issues brought forward and that they can be used as a reference for all stakeholders.

Now it is time for the NB-MED to scrutinize the proposed responses and see if they are also acceptable to all members of NB-MED. The NB-MED comments are kindly awaited by the end of October 2011, at the same e-mail address that was used for the initial submission of the issues: 60601Ed3.NBMED.issues@gmail.com, using the form supplied together with this document.

Happy reading!

The 60601-1 Issues Team:

Dr. Wolfgang Leetz, Dr. Peter Linders Dr. Klaus Neuder Mr. Martin Schneeberg