Big News!!!

IEC published ahead of schedule 6 of the 8 standards from the IEC 60601 Amendments Project. These standards are in Consolidated format meaning the latest edition plus amendments are all consolidated together. IEC notes this as a CSV. On 22 July 5 standards that published were: IEC 60601-1-6 Ed. 3.2, IEC 60601-1-9 Ed. 1.2, IEC 60601-1-10 Ed. 1.2, IEC 60601-1-11 Ed. 2.1, IEC 60601-1-12 Ed. 1.1. On 23 July 2020 IEC 60601-1-8 Ed. 2.2 was also published https://bit.ly/2Bui5mK
The other IEC 60601 Amendments (2 standards) still to be published include — IEC 60601-1 (ed. 3.2), IEC 60601-1-2 (Ed. 4.1) and maybe published as early as the end of this month (rumor has it but looking more likely) but it could be til Sept time range too.

Join us for a webinar on July 29, 9AM PT (Noon ET) for a live Zoom conversation on the IEC 60601 Amendments Updates (the 8 standards being published now & soon) with Leo Eisner the “IEC 60601 Guy” of Eisner Safety Consultants and Rob Packard of Medical Device Academy.

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.

What’s it about: The presentation guides you through many significant issues concerning the design & development of wearable medical devices. Leo will provides an in-depth look at the FDA guidance documents that may apply to your wearables, including the Home Use Environment, Mobile Medical Applications,  Accessories, and General Wellness  guidances among additional broader based ones.

Join us for this audio conference presentation and bring your group up  to speed as Leo guides you through the wide variety of FDA Guidances that may apply to your Wearable Medical Device. This audio conference will cover:

• Does the FDA consider your  wearable a medical device?
• FDA’s Final Guidances on Mobile Medical Applications & Home Use Environment
• The differences between the IEC & AAMI Home Use Environment Medical Electrical Equipment and Systems Standard (60601-1-11) and it’s impact on the FDA Home Use Guidance
• Draft General Wellness & Accessories Guidances
• Additional Regulations that may impact your Wearable device beyond the FDA

Click here for the details on the presentation & discount ($50.00 off regular price) and also some other past presentations from FX Conferences that we have presented.

Leo Eisner will be speaking on Medical Device Wearables and the Current Thinking from FDA with respect to myriad of new guidance documents that may apply to your devices.  This presentation is being offered 2 times in July (Tuesday July 21, 10:00AM Eastern and Thursday July 23, 1:00PM Eastern).  The best thing is you don’t have to travel to go to this presentation just dial in, download the material and you are set to learn from an industry expert.  As a special thank you for visiting us at Eisner Safety Consultants you can get a $50.00 (US$) discount.

Sign up now to take away some really valuable information in this fast moving industry.

What’s it about: This audio conference presentation guides attendees through many of the significant issues concerning the development of wearable medical devices. Leo provides an in-depth look at the guidance documents that may apply to your wearables, including the Mobile Medical Applications, Home Use Environment, General Wellness, and Accessories guidances among additional broader based ones.

Join us for this audio conference presentation and ease your regulatory stress as Leo guides you through the wide variety of FDA Guidances that may apply to your Wearable Medical Device. This audio conference will cover:

• Is your wearable a medical device per the FDA?
• FDA’s Final Mobile Medical Applications & Home Use Environment Guidances
• The differences between the IEC & AAMI versions of 60601-1-11 (Home Use Environment Medical Electrical Equipment and Systems) Standard and how it impacts your use of the Home Use Guidance
• Draft General Wellness & Accessories Guidances
• Other Regulations that can apply to Wearables outside of FDA
• Understanding which Recognized Consensus Standards may apply to your device

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.

IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3^rd ed. Published

This post discusses the recently published Guidance IEC TR 60601-4-3:2015 that issues interpretations of IEC 60601-1, 3rd ed. and edition 3.1.

The technical report tiled IEC TR 60601-4-3:2015 Guidance & interpretation – Considerations of unaddressed safety aspects in the 3^rd ed of IEC 60601-1 & proposal for new requirements was released April 2015.  It deals with recommendations and interpretations of the IEC 60601-1, 3^rd ed. and edition 3.1 (or 3^rd ed. + A1).  IEC Subcommittee (SC) 62A established a process under which Working Group (WG) 14 would develop recommendations regarding problems of interpretation or application of IEC 60601-1.  I am a member of this WG.  Many of the WG14 experts are employed by test laboratories and manufacturers and have many years experience applying IEC 60601-1 to MEDICAL ELECTRICAL EQUIPMENT.  The one thing to be crystal clear about is in the INTRODUCTION of the document it says:

“While the National Committee members of SC 62A nominate these experts, their recommendations were not to be formally adopted through any official voting procedure. To reinforce this process, the Subcommittee specifically directed that the following note appear on every page of the resulting informational circular:

IMPORTANT NOTE: Per the 62A decision at Sydney…, the 62A Secretary is circulating this recommendation,…regarding problems of interpretation or application of IEC 60601-1 to all P-Member NCs.

This recommendation/interpretation is the result of considerations by a group of nominated experts and has not been formally adopted through any National Committee voting procedure. Distribution is only for information.

The INTRODUCTION of this Technical Report goes on to say:

“This technical report is intended to convey the results of WG 14’s work to interested parties such as MANUFACTURERS and test laboratories while retaining the informative nature of the material.

This first edition of IEC TR 60601-4-3 contains 93 recommendations, numbered 101 to 193. All these recommendations are based upon IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

The numbering starts with 101 instead of just 1 to ensure that these WG 14 recommendations (101 to 193) will not accidentally be confused with previous issued WG 14 recommendations 1 to 63, which are based on the second edition of IEC 60601-1 and published in IEC TR 62296.”

The other purpose of this document is that these recommendations may be potential sources for some of the changes to the IEC 60601-1 standard when it is up for it’s next round of changes.  The standards committees, working groups, and maintenance committees for IEC 60601-1 and it’s collateral standards (IEC 60601-1-XX) are in discussion if the next revision will start late this year or early next year.  There is a meeting of all the TC 62 (& SC62A – D) committees in Kobe Japan in Nov 2015 that will discuss this and probably have a formal vote to decide on the fate of the next revision of IEC 60601-1.  I plan to be at these meetings and involved in the discussions and decisions. If this vote is positive the earliest the changes would occur is sometime in 2019.  Stay tuned for more updates on the potential changes to the IEC 60601-1 standards and it’s related collateral standards.

As there are 93 recommendations sheets I will not note all of them in the below list but a sampling showing a cross section of the ones that draw my attention.  You can see from the list below that many of these were not addressed fully in the standard and this is the start of the resolution to these issues. Many of test houses use this document as their interpretations that they rely on until these decisions are finalized by being adopted into the next revision of the applicable standard (primarily IEC 60601-1).  But realize as the boxed text says these are not formalized so your test lab may not rely on them.  I would suggest that you check first with your Test Lab on the specific issues before assuming they are their interpretations.  You don’t want to use these and find out at the end of your test project that your lab doesn’t agree to the perspective on one or more of these recommendation sheets.  I would hate to see you redesign a product to find out the solution doesn’t meet the requirements for your lab.  As mentioned many labs do accept these but with added text box please be diligent and check first:

3.2.101             Total PATIENT LEAKAGE CURRENT of a ME SYSTEM

3.2.102             Pollution degree for MOPP

3.2.103             Transients on d.c. mains

3.2.104             Altitude factor for DEFIBRILLATION-PROOF APPLIED PARTS

3.2.105             Defibrillation energy protection for MOOP / MOPP

3.2.106             Overvoltage categories III and IV

3.2.107             Pollution degree related to different micro/macro environments

3.2.108             Warnings versus ALARM SIGNALS

3.2.109             Single Y1 capacitor for MOPP

3.2.111             CREEPAGE DISTANCE and AIR CLEARANCE for dental equipment

3.2.112             Short circuiting of one constituent part of DOUBLE INSULATION

3.2.113             Instability in transport position

3.2.116             Instability excluding transport position

3.2.119             Test equipment for recurrent tests according to IEC 62353 testing used within IEC 60601-1 type approval testing

3.2.124             WORKING VOLTAGE measurement

3.2.125             Defibrillation test

3.2.127             PERMANENTLY INSTALLED ME EQUIPMENT in the HOME HEALTHCARE ENVIRONMENT

3.2.129             Push buttons

3.2.132             Eye-verification of tester before legibility test

3.2.125             Labeling: spare parts vs. detachable parts vs. ACCESSORIES

3.2.144             Impedance of a PROTECTIVE EARTH CONDUCTOR within a DETACHABLE POWER SUPPLY CORD

3.2.149             Expected voltage on SIP/SOPs

3.2.151             COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS

3.2.153             Critical components

3.2.166             Keep dry and umbrella symbol

3.2.167             MOBILE and STATIONARY ME EQUIPMENT with wheels

3.2.175             Biocompatibility for quasi APPLIED PARTS

3.2.182             Chargers for ME EQUIPMENT used at home

3.2.186             Rationale for IP2X

3.2.187             Battery – limited power

3.2.191             The SIP/SOP pin to earth TOUCH CURRENT

3.2.193             MAINS VOLTAGE on APPLIED PART

This is a great resource to have throughout your design process and through the testing and beyond.  Always have it available so you can leverage the knowledge of these WG14 experts, including myself.  You can purchase this document from IEC, AAMI, and many other sources.  Go to http://www.eisnersafety.com/links/ to find a listing of standards Sales Organizations and also Standards Organizations.

We are in the process of setting up a standards reconnaissance service where we monitor the MEDICAL ELECTRICAL EQUIPMENT and HOME USE MEDICAL ELECTRICAL standards of your choice.  If you are interested in this service please contact Leo Eisner at Leo@EisnerSafety.com or 503-244-6151.  We would be happy to discuss what we can do for your organization as Leo is on many of the standards committees that these standards are involved with.  Below is a summary of my involvement in these committees.

Leo is a co-chair of the U.S. TAG (technical advisory group) for IEC/SC 62D, a member of the US TAG for TC 62 (Electrical Equipment in Medical Practice), SC 62A (Common Aspects of Electrical Equipment Used in Medical Practice) and SC 62D (Electromedical equipment).  He is the convener of SC62D JWG9 “Lens removal and vitrectomy devices for ophthalmic surgery”.  Leo is a member of the TC 62/SC 62A/WG 14 (Testing to General Safety Standard – The Working Group is chartered to develop recommendations regarding interpretation & application of IEC 60601-1 to testing of medical electrical equipment, and to deal with general testing requirements not assigned to other maintenance teams.)  To support the increase in demand for medical device Home Use and Wearables Leo is a member of the AAMI committee for Home Use Medical Devices and the US TAG for Active Assisted Living Syc (System Committee for all devices in various categories for the elderly which includes the home use medical device industry).

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.   

Buyer Beware – Nursing Home Use Issue:

The FDA draft guidance says that the Home Use environment doesn’t include the use of a medical device in a “professional healthcare facility” (a defined term in the draft guidance) setting as noted in the definition for a “home use device”.  So, that means if you have a device that is designed only for use in a nursing home environment (a “professional healthcare facility” setting per the FDA’s interpretation) that the FDA won’t consider it to fall under the FDA’s draft guidance document and therefore under IEC 60601-1-11:2010 (1st ed.) which is the standard the FDA draft guidance document mentions exclusively, in terms of medical electrical equipment home use device standard.

I noted that the AAMI version of IEC 60601-1-11 standard which is titled “ANSI/AAMI HA60601-1-11:2011 (IEC 60601-1-11:2010, MOD)” has some US national deviations.  The National Deviation of import is that note 2 of the definition for “Home Healthcare Environment” (sub-clause 3.2) has been changed from saying that a nursing home is considered to be the “Home Healthcare Environment” to be a “professional healthcare facility”.   This spurred me to check the FDA’s List of Recognized Consensus Standards and the standard the FDA has Recognized for this issue is the IEC 60601-1-11:2010 version of the standard and not the AAMI version.  In the FDA’s Recognition it states “While this standard (IEC 60601-1-11:2010) recognizes long term care facilities as home use environment, FDA does not consider long term care facilities to be home use environment.”  This surprised me, somewhat, as the AAMI standard has the exception specifically stated right in the US National Deviations and the FDA’s lead for the Home Healthcare Initiative Mary Brady is one of the two co-chairs for the AAMI version of the standard.  Meaning it is clear to me that the FDA was well aware of the national deviation that ended up in the US National standard ANSI/AAMI HA60601-1-11 whereas it is not in the IEC version of the standard and never could be as it is an international standard and therefore national deviations are not allowed. This implies to me that the FDA made a mistake (dare I say such a thing) and should have referenced the AAMI HA60601-1-11:2011 standard instead of the IEC 60601-1-11:2010 standard in the FDA draft guidance and as the US National Recognized Consensus Standard.

So the current bottom line is this (remember it is a draft guidance so it may change):  If you have a device intended only for the nursing home environment and you go to a Safety Agency (i.e. UL, CSA, Intertek, TÜV SÜD, etc.) for a Safety Certification Mark you may be forced into the Home Use standard under IEC 60601-1-11:2010 unless you point out to the Safety Test House that there is a US deviation under the AAMI version (AAMI HA60601-1-11:2011) which says that Nursing Home Equipment is a professional use device which means the standard wouldn’t apply.  That is only if you are going for the US market only.  If you also want the EU or Canada or another country it is likely you may end up needing to get a Safety Agency Mark to IEC 60601-1-11:2010.  If you do get the Nursing Home Use device Safety Agency certified to IEC 60601-1-11:2010 and you go to the FDA for a pre-market submission (i.e. 510(k)) with this as part of your market clearance test data and you use the FDA draft guidance for home use, as well, you may run into some trouble because now the FDA may say this isn’t a Home Use Device per the draft guidance and so they may ask a lot of questions or they could ask you to rethink your approach and resubmit when you get things straight.

MD&DI Articles:

The two articles are “FDA’s Home Use Draft Guidance: Good But Not Gospel” and the really heat breaking story “How a Bad IV Pump Got into Nancy Stark’s Home”.  I hope these articles give you some perspective on the draft guidance document and I know I will be sending in a comment to the FDA in regard to the Home Use Draft Guidance based on the above “Buyer Beware – Nursing Home Use Issue” so hopefully the FDA can clarify this and make it clearer to the user of the Guidance document and that it links better to the applicable standard.

Related Articles:

FDA on Quest to Standardize Mandatory MedDvc Labeling

FDA Issues Draft Guidance on MedDvcs Intended for Home Use

Topic: “Implications of the Electro-medical Standards IEC 60601-1-11:2010 & Proposed IEC 60601-1-12” The Medical Electrical Device Collateral Standards in the Home Healthcare Environment and the Proposed Emergency Medical Services Environment, respectively

Presenter: Leo Eisner of Eisner Safety Consultants

When: March 3, 2011 (Thursday), 8:30 – 9:30AM (Pacific), 11:30AM – 12:30PM (Eastern)

Where: At your office or conference room (No travel required)

What’s it about: Get up to speed on the latest and developing requirements for the electro-medical collateral standards for the home healthcare environment (HHE) IEC 60601-1-11:2010 and the proposed IEC 60601-1-12 standard for the emergency medical environment (EMS).  Is your company ready for the implications of these standards as you will have regulatory requirements for the HHE standard come up soon (depending on the country of concern) and it will be similar once the EMS standard is published.

In this audio conference, Leo Eisner guides you through IEC 60601-1-11:2010 with new definitions, additions and changes to the general standard. The presentation reviews the significant issues including earthing requirements and additional mechanical and environmental tests. It also compares the requirements of each standard to provide a perspective on what the EMS may look like vs. the HHE standard.

Cost & Registration: Fx Conferences registration page for this event. Cost is normally $249.00 but with the Eisner Safety Consultants special discount you pay only $199.00. When checking out use the $50.00 discount code AF2009EIS.

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