Near the end of writing this article I had an unfortunate incident that I personally had to use a home use medical devices for 3 weeks of IV antibiotics (syringe pump – like an infusion pump but with a syringe instead of an IV bag) after a knee joint infection that I had to have emergent surgery & stay in the hospital for 2 days in Early June 2016.  I was out of work for about a month and so I got a close birds eye view of why the medical device and wellness device markets are exploding.  This explosion of interest comes from several factors including the “Super aging” of societies around the globe, Internet of Things (IoT), the portability of devices, the growth of wearable technologies and other factors discussed in the article.

There is a huge need to support those at home that are sick, injured, has an acute issue or chronic illness that want a comfortable life and would rather stay at home then be in a sterile hospital or other clinical setting any longer than they have too.  I know I was ready to get home after 2 days in the hospital, even though I had to rest at home, I was much more comfortable at home than in the hospital setting.  So, now I can appreciate how important it is to have these medical and wellness devices evaluated for the proper environment and proper standard(s) and to meet national regulations.   One of the issues that is important to this conversation is the blurry line between home use medical devices and wellness devices.  FDA has written guidances for both Home Use Medical Devices and Wellness Devices to clarify from their perspective.  There, also is a newer IEC System Committee called Active Assistive Living (SyC AAL) that is looking at the gaps in standards and other IEC technical documents for home use medical devices and non-medical devices (Some being wellness devices).  The article goes into detail on this SyC AAL and also looks at the medical electrical device standards focused around Home Use Medical Electrical Devices.

Enjoy the article and if you have interest in or need help with the IEC 60601-1 series, home use medical electrical devices or the SyC AAL please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants.

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>

Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed markets of US, EU, etc. but also the emerging markets (e.g. China, Brazil, etc.)

Our new service helps you identify the required standards and editions for your intended markets.                                                                   

Our service helps medical electrical device manufacturers (our specific focus of our database) keep up to date on new standards, updates to existing standards, and draft standards under development. This assures you can plan ahead of any major changes.

We reduce your burden on this time consuming task, so you can focus on what you are good at – developing products.

We do this at very reasonable rates.  We are offering to early adopters an extra discount on the price and extra time (3 months) will be added to the first year subscription. 

See our demo page for the types of reports we generate for the service. Find out more about the service.

We decided to take a little extra time to capture the large amount of information involved.. We will be Live by Mid Oct 2015.

Sign-up now for a live release notification and you will receive a special limited time offer that no one else will receive after we go live!! If you would also like to receive our Eisner Safety Consultants Newsletter sign-up here. Also, early adopters get an extra discount on the price and will get an additional 3 months added to their first year subscription if you sign-up in time.

What does the Service Provide:

The service includes several databases:

1. The Standards database is the primary focus. It includes standards, technical reports, technical specifications and guides. It includes new documents, updates to existing documents, as well as drafts under development (e.g. New Work Proposals, Committee Drafts, etc.)
2. List of standards publishers and the associated country.
3. List of Medical Device Regulators and their websites (if available).
4. Guidance Documents related to the standards for key markets. [Coming Soon]

A periodic report** is provided as part of the service.

All paid subscribers will have the ability to:

• Run searches of subscribed databases
• Print out search results from displayed data
• Print out tables of results in tabular format
• Export data for generation of your own reports (based on terms of service)
• Multiple user log-in for your company (limited to 5 unique user log-ins)

Discount for Initial release: We are releasing the database in stages, the early adopters (Current stage – stage 1) will get a discount (20%) for the first annual subscription cycle and an additional 3 months added to their subscription if you sign-up in time.

Sign-up now to receive a live release notification and you will receive a special limited time offer that no one else will receive after we go live!! If you would also like to receive our Eisner Safety Consultants Newsletter sign-up here.

Stage 2 will add Guidance Documents for the US, Canada, and EU. Also, list of standards publishers and the associated country will be expanded to cover 50+ countries. Stage 2 will be released by early 2016.

Stage 3 will expand the standards database to include US, EU, and Canadian versions of the IEC standards & IEC/ISO joint documents. It will also expand the regulators information and their websites beyond the key markets. Stage 3 will be released early Spring 2016.

Stage 4 will expand the standards database to include the supporting (non-electrical) medical standards used for your regulatory submissions e.g. ISO 10993 series, ISO 15223-1, etc. Stage 4 will be released early Fall 2016.

View details on the Subscription Levels

Please feel free to contact me with any questions you may have. I can be reached by e-mail or phone at Leo@EisnerSafety.com and 503-244-6151 (Office) and 503-709-8328 (Cell).

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).

Please welcome Mary Weick-Brady to our growing team that can support your medical device policy, regulatory, safety certification, and quality system needs. To find out more about her background and the rest of the Eisner Safety Consultants team members please check out our Associates web page.

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).

Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines?  How much time does it take to put this list together and how much effort does it take to keep the list updated? If this is a struggle for your organization to keep up with all the different data sources we have the solution for you at a reasonable price. A Standards Reconnaissance Subscription Service to help medical electrical device manufacturers keep up to date on all the changes that occur for these documents so you are prepared for future changes well ahead of the norm and you are able to stay up to date on your list of standards. The focus of this service will be on the documents for medical electrical equipment & systems (MEE&S = IEC TC 62, SC 62A – 62D) and home use medical electrical equipment & systems (Home Use MEE&S = IEC Active Assisted Living System Committee (IEC AAL SyC) and any other Home Use medical electrical equipment documents from the IEC TC 62, SC 62A – 62D including IEC 60601-1-11 Home Use Environment).

We plan to go live with the db by the end of Sept 2015.

Please reserve your spot by September 28, 2015 for this db subscription service.

Some of the features will include [For Paid Subscribers unless noted otherwise]:

• Notification e-mails when changes occur (i.e. Change in transition information from FDA for a standard) and new records are entered into the db.
• Receive either 2 or 4 reports per year (depending on Subscription level) summarizing:
  • key issues of that report cycle for MEE&S or home Use MEE&S,
  • estimated timeline for the publication of draft standards & other relevant documents of significance, and
  • full listing of all the documents in your part of the db with status information.
• Access to our searchable db (depending on Subscription level access to the either the MEE&S or Home Use MEE&S part of the db or the whole db) on our dedicated db website if you are a paid subscriber. [Limited access for free level of service with 10 – 15 standards (pre-defined)]
• Print out db search results the way you want them
• Export db search results for your use (limited by the terms & conditions of the db)

There are several parts of this db [For Paid Subscribers unless noted otherwise]:

• Standards db – including information on the standards, technical reports, technical specifications, and publicly available specifications that are active or current, in draft or development which would include voting level documents such as New Work Proposals, Committee Drafts, etc., and withdrawn documents (The previous version of the active standard).
• List of standards publishers & associated country (this will cover 50+ countries) [includes free service level],
• List of Medical Device Regulators with their websites, if available, for a selection of countries including all the of EU & EFTA countries.  We plan to expand this to include all countries in the world by the end of Stage 2 (below),
• Guidance Documents – Guidance documents that the regulatory bodies use for their national regulatory systems. Like for the US, Canada, & Europe. They will be added sometime after going live by end of stage 2 or 3 (see below).

Once the db goes live you can check out how the db works by accessing the free level of service to view a few examples of current standards (about 10 to 15). With the free service level you will be able to use most of the db features set other than obtaining reports, the update notification service, but you will not have access to List of Medical Device Regulators db of Guidance documents db.

Pricing starts at only:

• $4,500/year for Base Entry Subscription (2 reports per year and select either MEE&S or Home Use MEE&S part of db),
• $6,500/year for Mid-Level Subscription (4 reports per year and full access to db), or
• $9,000/year & up for Premium Subscription (2 personalized reports for your company’s needs based on conversations with Leo Eisner, 2 reports per year from the Premium Subscription level, and full access to db)
  All payments to be paid in US$ only.

We plan to go live with the db by the end of Sept 2015. Since we will be releasing the db in stages the early adopters will get a discount (20%) for the first annual subscription cycle and additionally we will throw in extra months to your subscription commensurate with how early you subscribe.  The earlier you subscribe the more free months will be added to your first yearly subscription for no additional charge.

Please reserve your spot by September 28, 2015 for this db subscription service and to guarantee a discounted first year price and to obtain extra months added for free. To reserve your spot for the Base entry or the Mid-Level Subscriptions please arrange a $750.00 (US$) deposit and for the Premium Subscriptions please arrange a $1,500.00 (US$) deposit. Contact us to arrange for deposit.

There will be a couple stages for the release of information for the db.  We plan on continual updates over time to provide a really valuable resource and continually make it better. The first stage will be complete prior to the official release of the db which will include all the updated information for the IEC based MEE&S & Home Use MEE&S documents including updates on the small number of joint IEC/ISO documents.  Stage 2 will be initiated just before the release of the db, which will include updates for the US, EU, and Canadian versions of the IEC & IEC/ISO MEE&S and Home Use MEE&S documents and IEC/ISO joint documents. We plan to have stage 2 completed around Jan 2016.  Stage 3 will include updated information adding in the supporting medical device (non-medical-electrical) documents you need for your regulatory submissions such as ISO 10993 series of standards, ISO 15223-1, etc.  This stage will initiate with the non-medical-electrical standards for IEC and ISO and in the future we will add other Standards Developers.  We expect to start on stage 3 around Jan 2016 and have not yet scheduled it’s completion.

Please contact Leo Eisner to find out more details about this db. He can be reached by e-mail or phone at Leo@EisnerSafety.com and 503-244-6151 (Office) and 503-709-8328 (Cell).

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.

This article discusses OSHA’s release of ANSI/AAMI ES60601-1:2005/(R)2012 + Amendments & timing of @ least 1 NRTL’s authorization to use it.

On 27 March 2014 OSHA announced thru a Federal Register Final Notice that they are incorporating new test standards into the list of ‘Appropriate NRTL* Program Test Standards’.  With this announcement they have officially added the US medical electrical standard “ANSI/AAMI ES60601-1:2005/(R)2012 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (with amendments)” as an ‘Appropriate NRTL Program Test Standard’.  The ES60601-1 weblink goes to the AAMI online store for the standard for your convenience. This announcement is something that many of us in the medical device industry have been waiting for about 8+ years – since the publication of IEC 60601-1:2005 in Dec 2005.  

*NRTL = Nationally Recognized Testing Laboratory. 

This version of the standard is currently the US National Version of IEC 60601-1:2005 + Amendment 1:2012 (A1) + Corrigendums + Interpretation Sheets + US National Deviations.  When I checked with my contact at OSHA he indicated that OSHA tries to make references to the ‘Appropriate NRTL Program Test Standards’ so as to “Future Proof” it, that is to say they make the reference fairly broad so if there are updates to the standard, like a new amendment, they still would be able to list the Standard as an “Appropriate Standard”.  He said it this way ‘I was not involved with writing the FR notice, but I suspect it was written that way to future proof the approval of the standard.  When OSHA approves a standard, we typically don’t publish a new FR notice when the standard is revised or a new edition is published.  Had we announced the specific amendment numbers it would have locked us into that specific version.  By being a bit more generic, it allows AAMI to revise and update the standard and we do not need to publish a new FR notice every time it is updated.  The important thing for us was we were not recognizing the original issuance of the AAMI standard, only A1 and later.’ As I mentioned in my previous posts on this subject of January 11, 2014 (Q&A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1) and of November 25, 2013 (OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards) OSHA never liked the original version of US version of IEC 60601-1:2005 (3^rd edition) but instead once A1 came out with its 496 changes (for the IEC standard)  that made the standard easier to use and more sensible that made all the difference in the world to OSHA. 

So, if you want to get a US NRTL Mark on your product to this standard you will have to update to 3^rd ed. + A1 when there is a NRTL that is approved for this standard as you will see an estimated time frame later in this article.  With FDA you have some time before 3^rd edition with A1 is required (stayed tune for further details in a future post) as you can use 3^rd edition without A1 until August 1, 2016 (as noted in FDA’s Recognized Consensus Standards List under Recognition Number 5-78 Supplemental Information Sheet (SIS) “ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012”).  You are also allowed to used 3^rd edition with A1 with FDA using Recognition Number 5-77.  A reminder that the Recognized Consensus Standards are not mandated to be used and are voluntary.  But I try to remind my clients if the Agency is used to reviewing to that Standard you are typically better off using this standard, even though voluntary, than starting from scratch and recreating the wheel.  It was invented a long time ago so why put yourself thru all this extra work?

Are We There Yet OSHA?

When I checked in with my contact on 27 March about the Federal Register Final Notice he indicated ‘that at least one lab has applied for recognition to AAMI ES 60601-1’ and that their ‘…policy is not to disclose who or how many have applied as we do not want to contribute to any business advantage or strategy that any NRTL may have or want.’  He also noted: ‘Organizations that already have UL 60601-1 in their scope simply need to demonstrate that they have the capability to evaluate and test the product in the areas that we identified as being significantly different.’  I went onto the OSHA NRTL website to see how many labs have UL 60601-1 currently as an ‘Appropriate’ Standard for their labs and of the 15 NRTL’s that exist 10 of them are approve d for this standard.  The NRTL’s that have UL 60601-1 as an ‘Appropriate’ Standard are noted in the below listing.  From the links in this listing you can click on them to go to the NRTL’s list of approved standards and also the locations of their test labs that fall under the NRTL program.:

• Canadian Standards Association (CSA)
• Curtis-Straus LLC (CSL)
• Intertek Testing Services NA, Inc. (ITSNA)
• MET Laboratories, Inc. (MET)
• QPS Evaluation Services Inc. (QPS)
• SGS North America, Inc. (SGS)
• TUV Rheinland of North America, Inc. (TUV)
• TÜV SÜD America, Inc. (TUVAM)
• TÜV SÜD Product Services GmbH (TUVPSG)
• Underwriters Laboratories Inc. (UL)

Once OSHA’s NRTL Program reviews the Lab’s submission assuming an acceptable submission and the application is complete with minimal Q&A back and forth with the NRTL my contact says then they can do a ‘fairly quick review’ and if that is the case he is expecting ‘the preliminary [Federal Register] notice(s) around early May’ for this initial one or more applications.  He goes on to say: ‘with the final notice(s), officially recognizing the NRTL for the standard’ being issued in the Federal Register around ‘sometime in Mid-June’.  He also says ‘Others will follow later depending on when they applied and the completeness of the application.’

So, What Does This Boil Down To? 

This means that at least one of the NRTL’s, and possibly more, that previously had approval for UL 60601-1 has already submitted an application to OSHA to be approved as a NRTL under the newer ‘Appropriate NRTL Program Standard’ ANSI/AAMI ES60601-1:2005/(R)2012 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (with amendments) and if things go smoothly, as expected this one or possibly more labs will be able to test and certify to this standard and issue an OSHA NRTL Certification Mark for the US that the medical device manufacture will be able to place on their product.  For more than 8 years this has not been possible and it is likely we are talking til at least June if not a bit longer before it is formally announced through a Final Federal Register Announcement.

Examples of the NRTL US or US & Canada Marks are below (is not a complete list of NRTL’s that have approval for UL 60601-1):

So, are you ready for ANSI/AAMI ES60601-1:2005/(R)2012 + A1 yet?  If, not and you want a NRTL Mark on your device you should start looking at what you need to do to update from either 3^rd edition or 2^nd edition of the standard if you have previously had your product tested &/or certified to these versions of the standard.

Oppps a Mistake in the Announcement about Future Standards:

In the Final Notice OSHA mentioned the comments they received briefly and one of them was from Mr. Dale Hallerberg of TÜV Rheinland North America (OSHA-2013-0012-0007).  You can access all the comments to these notices right here. In Dale’s original comments he said “Correct the standard name in Table 1 to reflect the proper designations, title, and number. Also include all corrigendum and amendment(s). This will include the current A1 as well as possible future amendments.  ANSI/AAMI ES 60601-1 including corrigendum and amendment(s)”  There were a couple other people that commented about the standard reference being wrong in the preliminary notice. 

But more importantly Dale went on to say: ‘Include 60601-1 collateral and particular standards in Table 1. “Collateral standards to the 60601-1 base standard: 60601-1-2, -1-3, -1-6, -1-8, -1-10, -1-11, and -1-12 as appropriate for the workplace safety of the product. ANSI versions shall be used when they exist.”  And also he said ‘Since it is impossible to keep up an accurate (list) of all the particulars, add them in a general way as follows: “Particular standards to the 60601-1 base standard as appropriate for the workplace safety of the product. ANSI versions shall be used when they exist.”’  So, he is asking the OSHA NRTL program to allow the use all of the applicable 60601 series standards, for workplace safety, including the Collaterals (i.e. 60601-1-8 = Alarm system standard) and Particulars (i.e. 60601-2-18 Endoscopic camera medical devices standard).  He also asked that they shouldn’t have to be aligned with ANSI only.  Note, that OSHA has told me they will only use a US based standards development organization for the standards they list as ‘Appropriate’ and so that precludes any organization outside of the USA, such as IEC, ISO, CENELEC and CEN (European equivalents of IEC & ISO respectively) to name a few.

OSHA mistakenly printed the following text which has a few problems:

“Mr. Dale Hallerberg stated that the list of appropriate standards should include, in addition to ANSI/AAMI ES60601-1:2005/(R)2012, standards that are collateral to ANSI/AAMI ES60601-1:2005/(R)2012, such as ANSI/AAMI ES60601-1-2 through ANSI/AAMI ES60601-1-12 (OSHA-2013-0012-0007).”

1. The first reference to “ANSI/AAMI ES60601-1:2005/(R)2012” doesn’t include the A1 which is critical to OSHA’s announcement as without A1 they would not be announcing this version of the standard.
2. The big issue is there are no such standards as ANSI/AAMI ES60601-1-2 through ANSI/AAMI ES60601-1-12. The closest thing to any of these references is there is an AAMI standard for 60601-1-11 which is actually ANSI/AAMI HA60601-1-11:2011 MEDICAL ELECTRICAL EQUIPMENT – Part 1-11:General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010, MOD).  The only other collateral standard that is issued thru AAMI via ANSI is ANSI/AAMI/IEC 60601-1-2:2007/(R)2012 (EMC).  Also, OSHA did not mention in the Final Notice Dale’s reference to the Particular standards.  It is hard to know if that was a mistake or if they intentionally left out the reference to the Particular Standards for some reason.

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.  We have several associates that can assist with this type of work.

Sign-up for our monthly newsletter to keep up to date on all our posts.  Make sure to reply to the confirmation e-mail otherwise you won’t be signed up. (If you don’t see that e-mail check your spam or junk mail folders).

Why do I need to classify my product for IEC 60601-1, 3^rd ed.? – The standard says you have to classify“…ME EQUIPMENT, or parts thereof, including applied parts…” as noted in sub-clause 6.1 of IEC 60601-1, 3^rd ed or 3^rd ed. with Amendment 1 of the standard.. But a more practical reason you would want to classify your products that fall under the scope of IEC 60601-1 (http://bit.ly/60601scope) is it is a helpful tool in identifying the requirements that apply to the device, and helps us in determining the test plan for the product to be tested.

This blog discusses the following FAQ’s:

• What are the various classifications that are used in IEC 60601-1, edition 3.1?
• What is an applied part? 
• What are the classifications for Protection Against Electric Shock? 
• Power Sources – External Class I, External Class II or Internal
• Applied Parts – B, BF, CF (also defibrillation-proof)
• Why do we have classifications for protection against electric shock?
• What are the classifications for protection against harmful ingress of water or particulate matter?
• Why do we have classifications for protection against harmful ingress of water or particulate matter?
• What are the classifications for methods of sterilization?
• Why do we have classification for the suitability in an oxygen rich environment?
• What are the classifications for modes of operation?