A good summary article on IEC e-Tech News about the IEC 60601 Series Amendments project that published last summer (2020) the General 60601-1, and Collateral standards (60601-1-XX). Please note that you need to read further comments in some of my articles about IEC 60601-1 for IEC 62368-1 and IEC 60601-1-2 for some additional details. One blog post is an article from InCompliance

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.

So are you ready for all the changes of Amendment 2 of IEC 60601-1 and all the Amendments?

Join us for a live free webinar on an Insider’s look at IEC60601 Amendments: detailed guidance from a committee member responsible for changes – Aug 27, 10 AM PT/ 1 PM ET

With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that the full scope of changes to the IEC60601 series is massive, creating a swell of confusion around understanding the updates & how to transition for compliance.

Greenlight Guru has teamed up with Leonard Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants to share his expertise on the topic, notably his contributions to The Amendments Project.

This in-depth webinar will cover clarifying details around the massive changes of the Amendments Project, provide guidance on updated standards already published, insider knowledge into updated standards not yet published & what to expect, & how to prepare accordingly for the impact it will have on your firm and product lines.

SOME OF THE CHANGES WE WILL COVER INCLUDE: 

• Updates to IEC 60601-1 (Medical Electrical Equipment)
• Updates to IEC 60601-1-2 (EMC)
• Updates to IEC 60601-1-8 (Alarms)
• Impacts of standard changes on:
  • Design
  • Regulatory approvals (i.e. FDA vs EU Notified Body – current vs new standards)
  • Safety certifications
  • Labeling / markings / packaging
  • Tests/ retesting
  • Essential Performance
  • Risk Management File
  • Usability Engineering File
  • Software Life Cycle Process
• Q&A session

WHO SHOULD ATTEND?

• R&D Engineers and Management
• Regulatory Affairs Professionals and Management
• Quality Professionals and Management
• Medical Device Executives
• Clinical Affairs Professionals and Management

It’s becoming increasingly more difficult for medical device manufacturers and consultants to stay up to date with the proliferation of changes in the regulatory landscape.

With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that the full scope of changes to the IEC 60601 series is massive, creating a swell of confusion around understanding the updates and how to transition for compliance.

We’ve teamed up with Leo Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants to share his expertise on the topic, notably his contributions to The Amendment Project.

This in-depth webinar will cover clarifying details around the massive changes of the IEC 60601 Amendments, provide guidance on the updated standards already published, insider knowledge into the updated standards not yet published and what to expect, and how to prepare accordingly for the impact it will have on your firm and product lines.

SPECIFICALLY THIS WEBINAR WILL COVER:

• Updates to IEC 60601-1 (Medical Electrical Equipment)
• Updates to IEC 60601-1-2 (EMC)
• Updates to IEC 60601-1-8 (Alarms)
• Impact of standard changes on:
  • Design
  • Regulatory approvals (i.e. FDA vs EU Notified Body – current vs new standards)
  • Safety certifications
  • Labeling / markings / packaging
  • Tests/ retesting
  • Essential Performance
  • Risk Management File
  • Usability Engineering File
  • Software Life Cycle Process
• Q&A session

Who Should Attend?

• R&D Engineers and Management
• Regulatory Affairs Professionals and Management
• Quality Professionals and Management
• Medical Device Executives
• Clinical Affairs Professionals and Management

ABOUT GREENLIGHT GURU

Greenlight Guru is the only medical device quality management system (MDQMS) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

ABOUT EISNER SAFETY CONSULTANTS

Eisner Safety Consultants supports your regulatory, quality systems, product safety, EMC, and engineering needs. Our experts speed your way to on-time product approvals via safety and regulatory agencies. We provide assistance with U.S., Canadian, European, & other international regulations. You can see a full list of the service offerings from Eisner Safety Consultants by visiting their website to learn more.

To sign up for this Zoom conversation click here. This Zoom Conversation is being hosted by Rob Packard of Medical Device Academy.

Learn about some of the major changes from the IEC 60601 Amendments coming during this Zoom conversation. Read the below infographic to get an understanding of which standards are being updated, when the updates are estimated, how long the proposed transition period is, what are some of the concerns to consider, and what ways can we help you prepare and train your staff up for these changes.

 Leo Eisner,

Topic:  Why Your Regulatory Strategy Can’t Ignore Medical Electrical Standards & Guidances

Track:  MD&M West: Regulatory & Quality Update

• The IEC 60601 series structure – why do all those dashes matter?
• An analysis of the medical electrical and related standards that have been recently updated or are in development, and how these standards interact with each other
• IEC 60601-1 and its collaterals (IEC 60601-1-XX standards) are going thru another set of changes – what are some of the impacts?
• What are the plans for aligning the particular standards (IEC 60601-2-XX & IEC/ISO 80601-2-XX) with the general (IEC 60601-1) and collateral standards in the 60601 series?
• Related standards that are in the process of change: ISO 14971, IEC 62366-1, and IEC 62304
• Standards and guidances inputs to your regulatory strategy (and product development plans) that need to be relayed to your regulatory, design and product development team members

Join in on the conversation thru LinkedIn

Medical Electrical Standards are constantly being changed and evolving and the amount of changes seems to be accelerating. All too often I hear clients complain that they didn’t know about a standard until way too late in the process and have had to redesign their product to meet regulatory requirements.

So how do you stay up-to-date on all these changes? Are you considering the implication of these standards when putting together your regulatory strategy? Do you know what standards are coming down the line and how they may impact your product design? Are these standards harmonized in different markets? Does your test lab always know what versions of standards you need to test too?

If you have a medical electrical device or a software as a medical device and your answer to any one or more of these questions is NO then this free 90 minute webinar is for you.

Take Aways from this Webinar:

• What medical electrical and related standards are being updated now and how they interact with each other.
• What is the schedule for the IEC 60601 Amendment Projects and what other standards (i.e. ISO 14971, IEC 62366-1, IEC 62304) will impact the project?
• Overview of the recently released Wireless Coexistence Standards for US.
• Why you may need to redesign your product to meet the EMC Standard IEC 60601-1-2:2014 (4th Ed.).
• How does testing under the CB Scheme impact your testing and regulatory strategies?
• Resources to keep track of standards from both a regulatory and standards development perspective

WHO SHOULD ATTEND?

• Medical Device Executives
• QA/RA Professionals at all levels
• Compliance Engineers
• Quality Engineers
• Design Engineers
• Project Management Engineers
• Senior Staff involved in management reviews per ISO 13485 for the standards update section

If you want to learn more about the IEC 60601-1 certification process you can read an article on the greenlight.guru blog of a presentation I gave awhile back on this process.

ABOUT THE PRESENTER:

This webinar is being lead by me (Leo Eisner), “The 60601-1 Guy”, founder and principal consultant at Eisner Safety Consultants and moderated by Jon Speer of greenlight guru.

Leo is a licensed professional engineer in safety engineering, a certified Quality System lead auditor, an expert in product safety for medical electrical devices (IEC 60601 series of standards) and an expert in CE marking for the medical device EU Directives.

Eisner Safety Consultants has helped countless clients thru the Product Safety and Regulatory maze over the 20 year history of the company. Leo has 30 years experience in product safety. Leo ran the Compliance Engineering Group at Karl Storz and was a Senior Product Safety engineer at TÜV Product Service.

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.

Speed your time to market by following the step-by-step instructions that I will discuss in this free, 90 minute webinar, so you can obtain your product certification to IEC 60601-1 series of standards quicker.

I will walk you through the steps to success for product testing by a certification agency (like UL, TÜV, BSI, Intertek, etc.) to the IEC 60601-1 series of standards on medical electrical equipment and systems.
Learn from the expert the mistakes others have made that have slowed down their certification process (and how you can avoid them).
Take proactive steps so your product doesn’t need to get redesigned after testing starts.

Take Aways from this Webinar:

• The IEC 60601-1 standards series & if they apply to your product.
• What you need to know to classify your products to the IEC 60601-1 series.
• What is an isolation diagram and how does that help me with my design?
• Understanding the importance of the Risk Management File and Essential Performance requirements.
• Determine the applicable tests for your device.
• What are the marking and labeling requirements for the device?
• Know your critical components.
• What pre-tests to run and what’s not worth testing?
• What samples are needed for testing?
• Resources to help with this process and ways to reduce the paperwork off your backs.  Get your free sample of Our Annual Standards Trends Report. Learn more about our Annual Standards Trends Report service.

If you want to get a prelude to this webinar listen to the podcast that discusses some of the Take Aways of this presentation.

About the presenter:

This webinar is being lead by Leonard “The 60601-1 Guy” Eisner, founder and principal consultant at Eisner Safety Consultants.

Leo is a licensed professional engineer in safety engineering, a certified Quality System lead auditor, an expert in product safety for medical electrical devices (IEC 60601 series of standards) and an expert in CE marking for the medical device EU Directives.

Leo has helped countless clients thru the Product Safety and Regulatory maze over his career. He has 30 years experience in product safety. Leo ran the Compliance Engineering Group at Karl Storz Imaging and was a Senior Product Safety engineer at TÜV Product Service. Prior to that Leo worked in a cross section of groups at U.L. for 9 years.

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

Eisner Safety Consultants provides affordable, on-time product approvals via safety & regulatory agencies to medical device companies. We provide assistance with U.S., Canadian, European, & other international regulations. Click here to learn more about our services we offer.

Eisner Safety Consultants has teamed up with greenlight.guru, a specialized electronic Quality Management System (eQMS) platform specifically designed for small to mid-size Medical Device companies. greenlight.guru will reduce your quality management system overhead, a web based system, which is easy and practical to use, will minimize your paper trail, and consequently your need for excessive consultant hours allowing you to focus on your product and getting to market. greenlight.guru and Eisner Safety Consultants are both well equipped with our specialized expertise and know how to get your device to market, and more importantly – STAY in market!

IEC 60601-1 is the gold standard for electrical medical devices around the world. IEC 60601 is a challenge for many companies that are developing electronic medical devices.  It’s wise to have a guide to help you understand and work through the process, and in this podcast I discuss with Jon Speer some guidance you can use.

You need to understand why this standard series is important when developing your electrical medical products for your regulatory submissions. You need to know what they are (join our webinar on the 15 Steps to Get IEC 60601-1 Approval on Dec 13, 2016 to get more details) and understanding how to incorporate them as part of your design and development process at the beginning rather at the end of the process.

Listen Now:

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In the Podcast Leo & Jon discuss:

● What makes the 60601 process different from the other regulatory compliance processes.

● Some of the details on the differences between creating a device for the ER vs. for home use and for use in other types of facilities.

● Tips on preparing for success when creating a timeline for getting through the 60601 process, as well as some of the steps involved.

● Differences between different types of safety labs and the criteria that’s vital to understand to help you make the right choice.

● What to do early in the process of product design and development to be sure you’re on the right track long before you get to the production phase.

● Why it’s vital to keep the 60601 standard in mind, not only when it comes to meeting the standards, but also when it comes to patient safety.

● The Annual Standards Trend Reports (click to get a sample report now & our new pricing) and how you can benefit your company and save money and time.

“Give yourself a buffer. There will be bumps in the road… guaranteed.”  “Some labs know medical very well, and there are a lot that don’t.” – Leo Eisner

A recommendation I tell my clients: When it comes to developing products to the IEC 60601 series of standards is that you need to know your product well enough to determine what standards apply early in the development process – from there you’ll know how much preparation and testing it will take.  If this is something you don’t have the expertise or the bandwidth for we can do it for you.  One tool I recommend for my clients is we can provide you with our Annual Standards Trend Reports (click for a sample report & our new pricing) so you are strategically positioned for the changes that are coming, the new standards in development and for the recently released standards you didn’t even know exist.  View a sample of our Annual Standards Trend Reports & our new pricing.  The Annual Standards Trend Reports can to help you navigate the standards that apply to you and save you a lot of money and time.

About The Global Medical Device Podcast:

The Global Medical Device Podcast powered by greenlight.guru is where today’s brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world’s leading medical device experts and companies.

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