(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 Your regulatory strategy for your products lines may be out of date which could delay your products getting to market on time.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.

One of the first questions clients ask before a project starts is, “Does this medical electrical product fall under IEC 60601-1?” Another common question clients ask is whether IEC 60601-1 applies to battery operated medical devices. To answer these questions, we must review and understand the scope (sub-clause 1.1) of IEC 60601-1 to determine if and how the IEC 60601-1 Standard applies to a medical electrical product.

This blog discusses the following points:

• Definitions
• Examples within Scope of IEC 60601-1:2005
• Examples not within Scope of IEC 60601-1:2005
• IEC 60601 & ISO 13485
• Third-Party Testing

From what I have determined the change in transition date is based on that OSHA’s NRTL (Nationally Recognized Test Laboratories) Program will be aligning with the FDA in terms of this standard and will hopefully be by the end of this year, if not sooner, they will be able to approve NRTL Test Labs to the US National Version of IEC 60601-1, 3^rd ed. which probably will be ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text).  FDA has been intending to, and I hope they do, come out with a guidance document for premarket submissions of medical electrical equipment and what their expectations are for applying the US National Version of IEC 60601-1, 3^rd edition.  Also, about 1-1/2 months ago FDA announced their concern about cyber-security for medical devices and hospital networks and so they issued a Safety Communication on June 13, 2013 to medical device manufacturers, hospitals, medical device user facilities, health care IT & procurements staff; & biomedical engineers; and they issued a draft guidance document on the issue on June 14, 2013.  To coordinate all these activities, draft guidance documents, and agencies FDA decided to extend the transition period for the US National version of IEC 60601-1, 3^rd ed. equivalent.

The IEC 60601 series of standards that FDA has Listed in the Recognized Consensus Standards Listing and some of the ISO 80601 series of standards that FDA has listed are updated in List 031 with this new transition date, unless it is a brand new standard being published on the List for the first time, along with other changes that were ready to be published.  The Cyber-security standards are listed in Recognition List 032 and are all new listings to the List of Recognized Consensus Standards.  There were many other changes with these Recognition Lists 031 & 032 which will officially be published in the Federal Register as of 6 August 2013 and the changes will officially be effective then but have already been issued prior to August 6, 2013 in the FDA’s Recognized Consensus Database. (Either one or two days prior).

Below is a summary of the more critical changes, from my perspective, for List 031.

New Standards Added to the FDA’s Recognition List 031 (Table 2 of List 031) of significance are:

There were also modifications to the List of Recognized Stds (Table 1 of List 031) of some importance.  The 60601 related standards were updated to align with the transition period of ANSI/AAMI ES60601-1 std along with other changes of importance as noted below.

In a future blog post we may discuss Recognition List 032 and the Cyber-security standards.

If you have any questions or if you would like our assistance with regard to these standards please feel free to contact us at Leo@EisnerSafety.com.

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

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

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

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

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

“The following HAZARDOUS SITUATIONS shall not occur;”

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

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

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

“This is clarified by the following:

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

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

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

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

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

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

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

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

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

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

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

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

This audio conference will cover:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In Addition to this article I have blogged on the topic a couple other times so if you want to see more material (original post) on the topic please continue to read on more of the details and experiences that impact many different people in many different ways (some good and some not so good) on the use of Medical Devices in the Home Use environment and how that impacts the users and their families that use these old and new technologies in the home.  Sometime these devices really are only designed for the hospital setting like some IV pumps, patients may have trouble with them to the point that patients pass away, which is a real tragedy no matter how you look at it.  There are 2 MD&DI articles on the Home Use Draft Guidance and one of the articles deals with an IV pump that probably shouldn’t have been in the home use environment with really sad results.

If you company needs support dealing with the IEC 60601-1-11 standard for Home Use Environment or with the FDA Home Use Draft Guidance document, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval we can provide you with regulatory, product safety, standards compliance, quality system services and more.  Please feel free to contact us at Leo@EisnerSafetty.com or 503-244-6151.   

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

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

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

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

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