A reminder that FDA Guidances and Recognized Consensus Standards are voluntary.  But I remind my clients’ that if you don’t use these voluntary documents for premarket submissions you make your life and the reviewer’s life a lot harder, typically.  So, I recommend, in most cases, to use these voluntary documents to speed up the process, in the long run.  In the short run, you may need to do more testing but if you don’t you risk the chance of your product not being accepted by the FDA.

The Guidance goes on to say that “the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device under review, as well as the use of appropriate FDA-recognized standards or appropriate consensus standards.”  The Guidance indicates that manufacturers typically reference in premarket submissions Recognized consesnsus national (US) and international standards such as IEC 60601-1-2²) (3rd or 4th edition) Medical Electrical Equipment EMC standard, device specific Particular Standards such as IEC 60601-2-XX, and lastly they reference other consensus standards for electrically-powered deevices that include information on EMC such as ISO 14708³ for active implantable medical devices.

The Guidance continues with a listing of details that FDA is expecting manufacturer’s provide in their premarket submissions, so the medical device EMC information is clear and consistent information for the submission, and are consistent with the specifications included in the standards, as referenced above, that are applied to the premarket submission.  The Guidance points to the FDA Recognized Consensus Standards database located at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

The rest of the Guidance, Section II “EMC Information”, details the list of items the FDA is expecting of the manufacturer’s for premarket submissions.  And of course the FDA leaves an opening for a broad statement at the end of the section that says: “Additional information not outlined above may be requested by FDA depending on intended use and intended use environment for specific active medical devices (e.g. implantable portions of active devices) to demonstrate the device’s claims regarding electromagnetic compatibility (EMC).”

If you need help with this FDA Draft Guidance or with IEC 60601-1-2 edition 3 or edition 4 or you are interested in our new Eisner Safety Consultants Standards Reconnaissance Database please email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

^{Footnotes cited from FDA Draft Guidance Document issued on 2 Nov 2015 titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”}

<sup>1. According to International definitions, “disturbance” is the cause and “interference” is the effect. In the US, “interference” is often used interchangeably for both cause and effect though more often for the cause. 
2. IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, IEC 60601-1-2:2014 [4th Ed.], Medical Electrical Equipment, Part 1 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests, AAMI/ANSI/IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, and AAMI/ANSI/IEC 60601-1-2: 2014 [4th Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests 
3. ISO 14708-3 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators</sup>

Topic: “Wearable Devices: How to Make Them Safe and Adhere to Regulations”

Presenters: Leo Eisner & Mary Weick-Brady of Eisner Safety Consultants and Bakul Patel of OC, CDRH, FDA

Session Leader: Seth Goldenberg, PhD, director, Global Regulatory Strategy, NAMSA

When: October 26, 2015 (Monday), 3:30PM – 5:00PM Eastern

Where: RAPS Regualtory Convergence Conference (Register to Join the Conference)

As the use of medical device wearables continues to grow, how does the medical device industry stay abreast of the proper regulations and standards that apply to these devices when seeking clearance? Industry and agency experts will discuss applicable regulations and standards and what is required for regulatory submissions for medical device wearables. Learn to better identify the applicable standards and regulations to consider for medical device wearables during regulatory submission.

If you need additional support for Wearable Medical Devices and Home Use Medical Devices email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

11 June 2015 – Scrip Regulatory Affairs – Article written by Leo Eisner titled “Everything you needed to know about who’s doing what where with IEC 60601-1 – Part 1” Article discusses how the standard (IEC 60601-1 3rd ed. or ed. 3.1) is being used by Regulatory & Standards Organizations for the USA and Canada.

To read this article please go to Featured Articles webpage. Thank you Scrip Regulatory Affairs for allowing us to post on our Featured Articles Page of our Website.  This is not for public distribution please refer your associates that you want to read the article directly to the Featured Articles webpage.

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).

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).

Our Associate Dale Hallerberg provided a short note about this recently published AAMI Guideline on Medical Device Safety Testing.

AAMI has published Technical Information Report (TIR) 62354:2015 “General testing procedures for medical electrical equipment”.  This report is available from AAMI at http://my.aami.org/store/SearchResults.aspx?searchterm=62354&searchoption=ALL. This document is identical to the IEC TR 62354:2014 published last September, and gives detailed guidance to manufacturers, test houses, and other interested parties on the steps involved in the safety testing of medical electrical equipment.  It builds on the test requirements of IEC 60601-1:1988 (including the collateral provisions of IEC 60601-1-1:2000) and IEC 60601-1:2005 and IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 but goes much further into testing details.  Examples of the content of the TIR include a description of the power supply needed for testing, the sequence of testing, the test equipment needed for each test, production-line tests, and much more.

This Report is not normative — which means it is not mandatory — however it gives excellent guidance and should be read and used by any laboratory interested in accurate, repeatable testing of medical electrical equipment or manufacturer and other interested parties in learning more about how the tests are conducted when their product goes to a test lab for IEC 60601-1 Certification Testing.  

If you need additional support for any of the IEC 60601 series of standards please email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

Part 2 of series Posts – “General Wellness” & “Medical Device Accessories” FDA Guidances in regard to Wearables. Join us @ 10X conference & learn more

From the previous “Wearables the rage but are they medical devices?” blog post I indicated that to determine if Wearables are medical devices you must a) review the definition of a medical device per Section 201(h) of the FD&C Act against the intended use of the device & it’s indications for use, and b) review a slew of recently released FDA guidance documents & related standards that supports those Guidance documents.

So, let’s continue with the “General Wellness” guidance document.  The draft guidance is titled “General Wellness – Policy for Low Risk Devices”

Many wearables may fall under the category of “general wellness”. Let’s see how this guidance may apply to Wearables.

The draft guidance document was recently released on January 20, 2015.  It covers the policy for low risk products that promote a healthy lifestyle (General wellness products). This could be like a Fitbit® or similar consumer oriented type of wearable devices that are on the market (Apple Watch, Microsoft Band, etc.). The FDA from a recent webinar and in the guidance document roughly said that it does not intend to examine, regulate & enforces “general wellness” products, if they meet the low risk definition that is in the guidance document.  This doesn’t mean that other Federal Agencies or Regulations won’t regulate these devices like the FTC, FCC, HIPAA, COPA, etc.  The guidance has several lists of examples of “general wellness” devices including weight management; stress management (i.e. a mobile apps that plays music to “soothe & relax” an individual and to “manage stress”); and products that promote physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure.  On the last page of the guidance there is a Decision Algorithm for General Wellness Products where the first section deals with “Does the product make only general wellness claims?” and the 2^nd part asks, “Does the product present inherent risks to a user’s safety (i.e. is the device low risk)?”  You need to make sure to clearly go through this Algorithm to decide where you product really falls.  You may want to enlist an FDA lawyer or a Regulatory Consultant if you are not familiar with the FDA regulations.

The next FDA Guidance document we will discuss is about Medical Device Accessories.  The Guidance is titled “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types”.  It is a draft guidance document and was issued on the same date as the “General Wellness” Guidance of 1/20/15.  The webinar that covered the “General Wellness” Draft Guidance also discussed this Guidance document and the Mobile Medical Applications Guidance as well, as they are interrelated to some extent and so it makes sense that they all have some component related to Wearables then, as well.  The Guidance deals with if the accessory needs to maintain the same classification as it’s parent device or if you can down classify the accessory and not be as restricted because of a higher classification. It depends on if the accessory has a lower risk profile than their parent device & if so may warrant being regulated in a lower class per the Guidance document.  So, less regulation on the accessory which is the theme of all the guidances in this blog post & for the Mobile Medical Applications Guidance too. The guidance advises the user of it that the FDA has jurisdiction over accessories because the definition of a medical device provided in FD&C Act Section 201(h) defines “device” to include, among other things, an “accessory”.  In the past the FDA traditionally determined classification of device accessories in 1 of 2 ways: 1) by inclusion in the same classification as the parent device thru either the 510(k) premarket notification clearance process, the PMA approval process or by inclusion in the classification regulation or order[1] for the parent device; or 2) by issuance of a unique, separate classification regulation or order for the accessory.  The scope of the guidance clarifies how FDA’s risk-based framework for classification applies to accessories to other medical devices. The guidance also describes use of the de novo classification process to classify accessories of a new type (not previously classified) under Section 513 (f)(2) of the FD&C Act.

This warps up this part of the blog post series for wearables and I will continue in a future post or two to cover additional guidances such as Cybersecuitry, EMC, and Wireless Guidances as related to Wearables.

If you want to learn more about these Wearable Guidance documents that are related to 510k submissions to the US FDA, I am teaching a 510k workshop in San Diego on May 4, 2015 as part of the Medical Device Group 10x Conference. To get a great last minute discount and to reserve a spot at the conference or just the workshop contact Joe Hage at jhage at MedicalDeviceEvents dot com and he will provide you a with special rate if you mention Eisner Safety Consultants referred you to him.

Two other consultants on the Eisner Safety Consultants team will teach the workshop: Allison Komiyama and Robert Packard.

Guidance documents to help you determine if your Wearable device is a medical device that needs FDA approval or not for US submissions.

Wearables may be the rage but what does your company need to do for an FDA medical device submission in the US (or do you even need one from the FDA?) with these devices that can be reconfigured and change what the product is – like tell you what your pulse is, measures your blood glucose, recommend certain healthy activities to improve your chance of surviving diabetes and the list seems to be limitless.  There is such a wide variety of what these device do now or will be able to do in the near future how do you know if they really are medical devices or are they just a consumer product or something in between?  It really depends on the intended use of the device and the indications for use of the device if they fall under the definition of a medical device per Section 201 (h) of the FD&C Act and also on a whole slew of recently released FDA Guidance documents and applicable standards that support some of these Guidance documents too.

The most common submission path for FDA for some class I and many class II products is to use a 510(k) submission.  These guidances all support this submission type and would be highly recommended to submit under this pathway if your wearable falls under these guidances and falls under a classification that requires a 510(k).

So, let’s look at this closer and see what we can figure out to help you along the way to developing that perfect medical (or non medical) wearable device that fits the market’s needs, wants, and desires too so you can sell millions of the perfect wearable medical device or not. 

What are all these new FDA Guidances about & how does that help me make this decision?

Since it seems like most wearables are used in many locations such as at school, at the office, at home, during a workout, walking the dog, at the beach, in the shower, while traveling, etc. and not just in a clinical setting like a hospital or a medical clinic (or an outpatient surgical center) that these devices now are considered under the FDA Final Guidance document for the Home Use Environment. Not all home use devices are wearables but I have worked on several consulting projects in the last couple years that are definitely home use medical devices that are wearables as well. Home Use is defined by this guidance document as:

Any environment other than a professional healthcare facility or clinical lab where a device may be used. 

This is a pretty wide definition and so many wearables will fall under home use just by this definition.  So, if you fall under this guidance document then your product should meet at least these FDA Recognized Consensus Standards[1]:

1. ANSI/AAMI HA 60601-1-11:201 – Medical electrical equipment used in the home healthcare environment (the US National Version of IEC 60601-1-11:2010[2]) in addition to,
2. ANSI/AAMI ES60601-1:2012 (Edition 3.1), Medical electrical equipment –General requirements for basic safety and essential performance (the US national version of IEC 60601-1:2012),
3. IEC or ANSI/AAMI/IEC 60601-1-2 Edition 4:2014-02, Medical electrical Equipment  – Collateral standard: Electromagnetic disturbances – Requirements and tests.  This is the 4^th ed. of the EMC requirements even though most medical device companies are still using the 3^rd ed. for US submissions the FDA is highly recommending that the 4^th ed. be used when submitting for the Home Use Environment Guidance document based on the most recent update to the Home Use Guidance of Nov 24, 2014. Note that if you already designed your product based on the 3^rd ed. of IEC 60601-1-2 you may need to redesign the product to meet the 4^th edition of the IEC 60601-1-2 standard per what my group’s EMC experts have discussed of recent. Another thing to consider, among many other factors is Usability of the device under
4. ANSI/AAMI/IEC 62366:2007/(R)2013, Medical devices—Application of usability engineering to medical devices And
5. ANSI/AAMI HE75:2009, Human factors engineering–Design of medical devices
6. The list goes on – refer to the Home Use Guidance document for more info.

Now that we touched on the Home Use Environment what other FDA Guidances should you consider in determining if your wearable will fall under FDA regulations and if the FDA will focus it’s energy on oversight of your wearable device as you define it.  That then has to be the Mobile Medical Applications (MMA) Final Guidance, Issued February 9, 2015.  The following graphic came straight from an FDA webinar on the subject and it really helps explain the striations (3 levels) of this Guidance document.

There is a lot of information in this 44 page Guidance with great examples of what an MMA is and not that you should really review closely.  It will help you figure out where your device falls in this pyramid of regulation and if your product is even considered a medical device or not.  The lower on this pyramid the less regulation will be enforced by the FDA, if at all (bottom level will not be under the FDA’s purview).  The middle level the FDA doesn’t plan to enforce regulatory oversight (truly this is what they said in the FDA webinar on this subject).  Realize there are other agencies & regulations outside of the FDA that likely will apply including under the FTC and HIPAA regulation.

To truly be an MMA (the top of the pyramid) the device needs to meet the definition of a medical device of Section 201(h) of the FD&C Act and either is intended to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device.  Some examples of MMA’s include control inflation or deflation of a blood-pressure cuff; MMA calibrate, control, or change settings of a cochlear implant; MMA’s that connect to bedside (or cardiac) monitors & transfer data to a central viewing station for display & active patient monitoring. 

The Lower Risk mobile apps (middle part of pyramid) that meet the medical device definition under Sect. 201(h) of the FD&C Act but are not considered MMA’s the FDA has decided not to enforce regulatory oversight at this time (Currently FDA won’t enforce design & development controls, registration, etc.).  But what happens if your device causes a major health risk (say you have a recall) or the FDA changes it’s mind down the line?  They have been known to change their minds on occasion and so I recommend from a business risk perspective to follow the regulatory requirements for your medical device OR if you want to take the risk and hope nothing happens that is something you should weigh closely before going that route.

We will continue this post in another post or two and cover additional guidances such as the “General Wellness – Policy for Low Risk Devices” and “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types” Guidances, Cybersecuitry, EMC, and Wireless Guidances.

If you want to learn more about these Wearable Guidance documents that are related to 510k submissions to the US FDA, I am teaching a 510k workshop in San Diego on May 4, 2015 as part of the Medical Device Group 10x Conference. Two other consultants on the Eisner Safety Consultants team will teach the workshop: Allison Komiyama and Robert Packard.

BIG News!!!  News, I have been waiting for many years now is that OSHA, finally, under it’s NRTL (Nationally Recognized Test Lab) program will be adding the US National version of the IEC 60601-1:05 + A1:12 medical electrical safety standard (= AAMI ES 60601-1:05/(R):12 + A1:12 + C1:09/(R):12 + A2:10/(R):12) to their ‘List of Appropriate’ NRTL Program Test Standards.  The announcement in the Federal Register is dated for 25 November 2013 but the list won’t be updated until at least early next year as comments, information, & documents in response to the notice, or requests for extension of time to make a submission are due by 26 December 2013.

What’s that mean to those manufacturers that have been waiting years to get a NRTL US Mark for their medical electrical product to 3rd ed. of 60601-1?  It means that OSHA is just announcing they are adding this standard to the ‘list of Appropriate Standards’ sometime early next year, if things run smoothly.  But does that mean the Test Agencies like UL, CSA, TÜV SÜD, & Intertek that have previously asked OSHA to add the US national version of 3rd ed. of the IEC 60601-1 standard to these lab’s ‘list of Appropriate’ standards will be automatically added to that list?  My guess, at this point, is that OSHA will have to qualify each test lab that wants to be added to this list for AAMI ES 60601-1.  How long will this take?  And what will that qualification look like as now OSHA has to deal with qualifying the safety test agencies for the review and approval of the risk management process for medical electrical devices (a new concept for them I would suspect), among other potential issues?  That’s a good set of questions and I have an e-mail into OSHA to ask all these types of questions and when I get some feedback from them I will send an update out to all of you.  

Note, the Notice in the Federal Register had a fairly major typo, which I already pointed out to my contact, and that is the notice should have identified the standard as AAMI ES 60601-1:05/(R):12 + A1:12 + C1:09/(R):12 + A2:10/(R):12 (this is the US National version of IEC 60601-1:05 + A1:12) and instead they had a big set of typos that says in this notice “AAMI ES 60601-1” (they missed all the details to id it as Amendment 1 – Ooooops) and the title they refer to is “Medical Electrical Equipment—Part 1-2: General requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Compatibility (third edition)”.  The items that are underlined, bolded and italicized are the wrong standard name.  And I believe they should be very specific for this version of the standard and that is why I am pointing out the full AAMI ES identifier in this post and sending it to my contact at OSHA. He already said they are checking into the typos.  Hopefully the typos can be fixed quickly so that it doesn’t slow down the process anymore.

So, hopefully by mid next year, or hopefully before then, OSHA will be able to say they have one or more of the NRTL’s online for issuing NRTL safety agency marks as that will mean those safety test agencies will be able to start to issue the NRTL mark to the AAMI ES 60601-1:05/(R):12 + A1:12 + C1:09/(R):12 + A2:10/(R):12 version of the standard.  So, another question comes up will the Safety Agencies be able to leverage from previous testing done by these Safety Test Agencies or will they need to start a totally new test project before they can issue the NRTL mark for this standard?  I will make sure that OSHA get’s all these questions and hopefully they will be able to respond to these questions and answers publicly.  That I really am not sure about yet. 

If your company needs help with edition 3.0 or 3.1 for AAMI ES 60601-1 or IEC or EN 60601-1 gap analysis, preparation of the risk management file for these versions of the standard, or training on the Standard, please contact Leo Eisner at: Leo@EisnerSafety.com.  

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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

As you know Risk management is a necessary, yet onerous, task when developing electro-medical devices. Since IEC 60601-1 3rd ed. was published, manufacturers have faced many new risk management challenges with respect to their electro-medical devices, especially home health devices.

Avoid the common pitfalls of risk management in IEC 60601-1 3rd ed. Experts will share case studies in their risk management practices for their own devices.

Come join us at the RAPS Convergence Conference to learn more on this subject.