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).

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).

This post discusses that EN60601-1:2006+Amendment 1 (A1):2013 has finally been Harmonized under the MDD.

This is really big news that many of us in the medical industry have been waiting to hear occur for quite awhile.

What’s The Big News About?

On 16 May 2014 the Official Journal of the European Union (OJEU) published an updated Harmonized Standards List for the MDD 93/42/EEC (2014/C 149/02), therefore making it a Harmonized Standard under the MDD.  Of the five changes to the list for “first publication” documents the one of concern for this post is EN 60601-1:2006 + A1:2013 (it is also known as Edition 3.1 which means 3rd edition of EN 60601-1 [published 2006] + Amendment 1 (or A1) [published 2013]).  The cessation of presumption of conformity for the EN 60601-1:2006 (3rd edition without A1) has been set to be 31 December 2017 ( a 3 year transition period) but there is more to the picture so please read on otherwise you will run into a problem before that date.

Remember That Harmonized Standards Are Voluntary:

NOTE: A reminder that EU Harmonized Standards are not mandatory to meet the Essential Requirements of the MDD but do help make it easier to meet the Directive than going it without the use of Harmonized Standards typically but it is your choice how to approach this issue. I do recommend, to my clients, that they use Harmonized Standards, when they can, since they are common standards that Notified Bodies and Test Houses understand and are familiar with.  So, it is easier to use a Harmonized Standard like EN 60601-1 than to prove, with a higher burden of proof, using a different standard(s) or internal specification(s), etc. that the Notified Bodies may not be as familiar with and then the manufacturer has a higher bar to prove to the Notified Body to prove they meet the Essential Requirements of the MDD.

What’s That Note All About?

In the recently released OJEU Harmonized Standards Listing for EN60601-1:2006+A1:2013 there is an extensive note that discusses the dates of cessation which reads verbatim:

“Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.”

What’s The Bottom Line?

So, what does the above text really mean?  You will need to consider the A1 Annex ZZ before the end of the transition period for the standard EN60601-1:2006 (3rd edition).  The EN60601-1:2006 transition period ends on 31 December 2017 but on 1 January 2016 you will need to comply, if using this voluntary standard, with the clauses of Annex ZZ of EN60601-1:2006+A1:2013 to be provided with the presumption of conformity that is needed to help meet the essential requirements of the EU Directive in relation to the EN60601-1 standard.  

To learn more about the Annex ZZ refer to the 2nd post in the below listing of past posts on the 60601-1 standard.

How Many Changes Are There in A1:2013 of EN 60601-1:2006 + A1:2013?

There are quite a few changes in A1 as there are 496 changes that were brought into the standard.  Why so many changes?  The original 3rd edition of the standard was released before it may have been totally ready but after about 10 years of development the standard committee decided they needed to get something out before the project would have been sent back to the drawing board (meaning it could have taken another couple years to release it) by IEC rules and also because at that point there was so much anticipation of the release by industry and the Test Houses the standard committee decided it was mature enough to get it out the door.  Of the 496 changes only about 70 of the changes are moderate to significant impact and the rest are editorial and minor corrections including typo corrections too.

For easy reference we have listed below some of our past posts on 60601-1 and 3rd edition + A1 which may be of interest to you.

1. Q&A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1
2. Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ
3. FDA Extends AAMI ES 60601-1 Transition Date to 31 Dec ’13 & Other Important Changes – Recognition Lists 031/032
4. IEC TR 62348:2012 Added in Assessment of impact of most significant changes of IEC 60601-1:2005 Amendment 1 (This Technical Report  talks about the significant and moderate changes to the standard of the 496 changes that were made to the standard.) 
5. When will IEC 60601-1:05+A1:12 turn into EN Standard?
6. IEC 60601-1:2012 Consolidated 3.1 Edition Just Published
7. Amendment 1 of IEC 60601-1:05 (3rd edition) has been published by IEC

So, you can get to the important areas for you I have split this blog into several sections that you can jump too quickly by clicking on the below links:

• When did the IEC 60601-1 A1 come out?
• What is the status of the EN 60601-1 A1?
• Is EN 60601-1:06 + A1:13 Harmonized under the MDD Yet?
• What about all the other EN 60601 series of standards?
• So, what is Annex ZA about?
• And what about Annex ZZ?

When did the IEC 60601-1 A1 come out?

Amendment 1 (A1) of IEC 60601-1:2005 (3^rd ed.) was published last summer on 13 July 2013 and the consolidated edition (edition 3.1 = IEC 60601-1:2005 + A1:2012) was published on 20 August 2012.  The consolidated edition is very useful as it shows all the redlines of the 496 changes that were made for A1 vs the original 3^rd ed.

What is the status of the EN 60601-1 A1?

So, for Europe it has taken over a year to get the EN (European Norm) of A1:2013 to EN 60601-1:2006 (third edition) to be ratified by CENELEC which was on 24 Sept 20013, then it became available for publication (Date of Availability) in Europe on 4 October 2013 and so now it is allowed to be published in Europe and must be implemented or published by all of the EU countries by 24 June 2014.  The only country that I have been able to find it published in is Denmark as a Dansk Standard (DS or in English it would be Danish Standards).  It is DS/EN 60601-1:06/A1:13 issued on 15 October 2013.

Is EN 60601-1:06 + A1:13 Harmonized under the MDD Yet?

The answer is a no, not yet but we are getting pretty close to it occurring.   It hasn’t been Harmonized yet but soon it will be approved as a Harmonized Standard.  This document tells a lot of the story for the history of the Harmonization process for EN 60601-1:06 + A1:13.  This version of the standard has been reviewed and approved for harmonization by the Consultants so its only a matter of publishing it in the Official Journal of the EU (OJ).

What about all the other EN 60601 series of standards?

If you read thru the document referenced in the previous paragraph you will find there are 41 total 60601 series standards in the pipeline that are all expected to flood out of the OJ as Harmonized Standards under the MDD by the end of the 1^st quarter of 2014.  That’s a lot of change to come in a short period of time.  But realize that is not the full series of 60601 standard out there & note there are Joint IEC/ISO projects that are titled 80601 series too.  So, keep your eyes and ears peeled and open to keep up with what will be happening soon.

So, what is Annex ZA about?

Annex ZA is a listing of normative (required or mandated) references to international publications with their corresponding European publications.  This is a list of the European & EU Harmonized standards.  This primarily changes most of the IEC and ISO standards that are referenced in IEC 60601-1:06 + A1:13 (ed. 3.1) to EN & EN ISO standards for the EN version of the standard.  The standards that change in the base of the standard are marked by (mod.) to indicate the original requirements have been modified by common modifications as noted in the beginning of Annex ZA.  There are some that stay as IEC & ISO standards but most change.  But that isn’t the bombshell.  When A1:12 of IEC 60601-1:05 was published a decision was made to go from dated references for the IEC 60601 series standards (i.e. IEC 60601-1-2:2007) to primarily undated references (IEC 60601-1-2), unless a specific standard reference didn’t meet the criteria for the change (most changes occurred and a few stayed as dated references).  The primary reason for this change was to make the standards development maintenance process of the whole series of standards (almost 60 standards in the series & growing) easier to update when there was a change in a Particular (i.e. IEC 60601-2-XX) or a Collateral standard (i.e. IEC 60601-1-XX).  About a year ago under the IEC A1 version of 60601-1 undated references came about but that now has been changed back to dated references in the EN version of the standard (EN60601-1:06 +A1:13).  This means, as it says at the beginning of Annex ZA, “For dated references, only the (dated) edition cited applies.”  Annex ZA also says “For undated references, the latest edition of the referenced document (including any amendments) applies.”

So, for the IEC series of 60601 standards you currently have the Collaterals and Particulars being updated or will be updated in the near future (now thru about 2 years from now) to reflect the undated standards references to filter through-out the whole series of IEC 60601 standards.  So, more change to keep an eye out for.  Some people would say you need to have a Master’s degree to keep up with this but you could rely on consultants, like me, as this is one of my many job duties is to keep up-to-date on standards development information so I can keep my client’s informed & up-to-date.

And what about Annex ZZ?

Annex ZZ is a fairly long section clocking in at 19 pages long and part of the focus is on the Risk Management Process of sub-clause 4.2.2 of EN 60601-1:06 + A1:13 as the EN ISO 14971:2012 standard is the Harmonized standard most recently called out in the EU MDD Harmonized List of Standards (a voluntary listing but easiest way to prove compliance too) and is a significant modification of ISO 14971:2007 with some major changes to it.  So read on for more details with respect to the changes for risk management, among other issues for this Annex ZZ.

Annex ZZ is titled the “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices”. Annex ZZ is a means for showing conformance to meeting the parts of the Essential Requirements (ER’s), Annex I, of the MDD under 93/42/EEC as amended by 2007/47/EC, that apply to the standard EN 60601-1:06 + A1:13.  This standard doesn’t confer compliance with all of the ER’s under the MDD only certain ER’s in whole or in part.  I am repeating the first page text of Annex ZZ in “quotes” below and then writing my commentary, in italics, to explain each section.

“This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association to provide a means of conforming to the Essential Requirements given in Annex I of the EC Directives 93/42/EEC as amended by 2007/47/EC.”

This means that EN 60601-1:06 + A1:13 Annex ZZ will be the means to prove conformance to the ER’s of the MDD in whole or part based on a mandate to CENELEC from the European Commission & EFTA.

“Once this standard will be cited in the Official Journal of the European Union under that Directive, compliance with the clauses of this standard given in Table ZZ.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements (ERs) of that Directive and associated EFTA regulations.”

Once this standard is Harmonized under the MDD (via publication thru the OJEU) compliance with the clauses of the standard, within the limits of the scope of the standard, cited in Table ZZ.1 confers a presumption of conformity with the corresponding ER’s of the MDD & associated EFTA regulations (MDD adopted by EFTA). 

 “NOTE 1     This standard is intended to be applied in its entirety only. Selected clauses or subclauses may be not applicable due to the specific type of equipment under consideration. It is necessary to understand and apply Clauses 1 to 5. It is also recommended to understand and apply those clauses which contain general requirements related to a specific subclause. Elements of the standard that are not cited in Table ZZ.1 may be relevant for the appropriate fulfilment of certain essential requirements through indirect reference, and for safety and performance aspects of the device, that are not addressed through essential requirements.”

You must use the whole standard.  You can’t just pick and choose clauses you need the whole enchilada otherwise not a valid evaluation of the product.  But you may be able to cite & provide justification that certain clauses & sub-clauses don’t apply to your specific device.  Clauses 1 thru 5 of the standard must be applied and understood completely and well.  These clauses include the scope of the standard, the object, how the Particular and Collateral standards of the 60601 series of standards apply, which standards are normative references and how they work (dated vs undated), terminology & definitions, general requirements which includes discussion of & requirements for:

• Conditions of the equipment to be tested and analyzed
• The Risk Management Process
• Essential Performance
• Expected Service Life
• Equivalent Safety
• Parts that touch the Patient but aren’t to be marked as Applied Parts
• Single Fault Condition
• Component requirements
• Use of High-Integrity Components
• Power Supply issues

And General Requirements for Testing the ME Equipment

• Type Tests
• Number of Samples for testing
• Environmental issues
• Test conditions
• Repairs and modifications
• Humidity preconditioning
• Sequence of tests
• Determination of Applied Parts vs Accessible Parts

 Also, all clauses that apply general requirements related to specific sub-clauses must be considered & addressed.  Even if there are specific sub-clauses that aren’t cited in the Table ZZ.1 that doesn’t mean they aren’t valid to help meet some of the ER’s even if indirectly & for safety & performance aspects of the device, not addressed through the ER’s.

“NOTE 2     Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance to the MDD (Directive 93/42/EEC amended by 2007/47/EC). This means that risks have to be reduced “as far as possible”, “to a minimum”, “to the lowest possible level”, “minimized” or “removed”, according to the wording of the corresponding essential requirement.”

Where there is a reference made from a clause of the standard EN 60601-1:06 + A1:13 to the risk management process, the risk management process needs to be in compliance with the MDD.  This means that risks have to be reduced according to the specific wording of the corresponding ER.  Such as with the wording “as far as possible”, “to a minimum”, etc.

“NOTE 3     With respect to note 4 of clause 4.2.2 General requirement for risk management, the manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the directive.”

Note 4 of clause 4.2.2 “General requirement for risk management” states:

“NOTE 4     Where requirements of this standard refer to freedom from unacceptable RISK, acceptability or unacceptability of this RISK is determined by the MANUFACTURER in accordance with the MANUFACTURER’S policy for determining acceptable RISK.” 

This infers that the standard IEC 60601-1:05 + A1:12 requires that Risk is determined by the Manufacturer’s policy for determining acceptable risk which is the Risk Management Process under ISO 14971:2007 per the IEC standard (ed. 3.1) but once you get into the MDD & EN Harmonized standard it will be EN ISO 14971:2012 based on the conversion done in Annex ZA.

So, continuing on — Risk is determined by the Manufacturer’s policy for determining acceptable risk which is the Risk Management Process under EN ISO 14971:2012 for the ER’s 1, 2, 5, 6, 7, 8, 9, 11 & 12 of the MDD.  When you look at Table ZZ.1 you will see in a greyed out area of the top of each ER section for ER’s 1, 2, 5, 6, 7, 8, 9, 11 & 12 there is a note that says “General Guidance note 2 and 3 shall be observed” which infers that you need to follow the risk management process stated in these specific ER’s per EN ISO 14971:2012 Annex ZA (for the MDD) which is where all the modifications of the Risk Management standard were made by the EU Commission causing total havoc for the EN ISO version of the standard even though not in the main text of the standard Annex ZA has caused a total mess of what was once a specific standard and now has been jumbled and makes it hard to meet risk management requirements for multiple countries when one of them is the EU and there are other countries involved as ISO 14971 & EN ISO 14971 are in direct conflict with each other.  You can meet one but not both at the same time from what I have surmised.

“NOTE 4     References in the clauses 3 to 17 or in the Annexes of this standard specify whether the normative references listed in Clause 2 as cited in Annex ZA are to be applied in whole or in part.”

Clauses 3 to 17 (the meat of the standard) and the Annexes of the standard EN 60601-1:06 + A1:13 specify whether the mandatory (normative) references listed in Clause 2 (the clause for all the Normative References of the standard), which in the EN version of the standard is replaced by the citations in Annex ZA for clause 2, are to be applied in whole (the whole standard) or in part (a certain portion of the standard) as noted in the standard itself.  

“NOTE 5     This Annex ZZ is based on Normative References according to Annex ZA, replacing the references in the core text.”

Annex ZZ of this EN 60601-1:06 + A1:13 standard is based on the Normative references of Annex ZA (Normative Standards that were replaced from IEC & ISO standards to the European EN, EN ISO, & HD standards in the EN 60601-1:06 + A1:13 version of the standard).  Bottom line this means that all the IEC 60601-1:05 + A1:12 normative references are to be replaced by the Annex ZA normative standards references for the EN 60601-1:06 + A1:13 version of the standard.

“WARNING: Other requirements and other EU Directives and Regulations may be applicable to the product(s) falling within the scope of this standard.”

This simply means that the MDD is not the only Directive that may apply.  Some examples of Directives and Regulations that may apply include the following examples:

• Restriction of Hazardous Substances (RoHS2) Directive 
• This is coming up for most medical device manufacturers in June of 2014.  That’s not a lot of time to get ready for this process.  If you would like to learn more about this process for the medical device manufacturer please join me in a presentation on RoHS2 for the Medical Device Industry on 17 Dec 2013.
• Waste of Electrical and Electronic Equipment (WEEE) Directive
• Machinery Directive
• Radio and Telecommunications Terminal Equipment (R&TTE) Directive
• Privacy / data protection Clinical data and other personal data Directive
• Regulation on electronic instructions for use of medical devices
• Etc.

Note, that Axon Lawyers has prepared a document for their local RAPS group on the associated Directives that may apply to your EU medical devices and they have been generous to allow all of us to have access to it.  So, thank you Erik Vollebregt for one of your many resources that has helped my clients and I to understand better the implication of the Warning in Annex ZZ of EN 60601-1:06 + A1:13. 

So, get a copy of the standard EN 60601-1:06 + A1:13 so you can have access to the important Annex ZA and Annex ZZ.   If you follow the details noted there you should be in good shape. Annex ZZ is a useful tool to make it easier to know what ERs are applicable to the 60601-1 standard and what is expected instead of doing it blindly for so many years without that support. Last week I actually used this table in Annex ZZ very successfully to audit a MDD Technical Files ER checklist and it provided a wealth of information that just made my life a lot easier and will make yours a lot easier too if you need to put an ER Checklist together for your next Technical File or for a Design Dossier too.

I remember when first working on the IEC based standard that I am a convener of (IEC/ISO 80601-2-58) I was requested to work on the parallel EN standard.  Someone in our Joint Working Group (JWG) suggested that we (the JWG) put together an Annex ZZ but I was later told by some in Europe the 60601 series of standards wasn’t doing that yet because of some political issues that I was never clear on. So, I guess we finally broke that cycle, many years later, and now many of the 60601 series of standards are slated to go thru this process (41 thru the end of 1^st quarter of 2014). I think at first probably the more popular ones will get processed and who knows how long it will take to get all of them processed thru.

If your company needs help with edition 3.0 or 3.1 for EN or IEC 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

I (as a medical device consultant, US TAG member of IEC SC 62A & 62D & Convener of SC62D JWG9 {IEC/ISO/AAMI/CENELEC 80601-2-58} and a past Notified Body Auditor) am really pleased to see the extremely hard work that has gone into this document and also in the value that it will pass on to all the stakeholders.  There are many stakeholders that were involved in this process including Notified Bodies, NB-MED EN 62304:2006 issues team (Thank you for your hard work.), NB-MED, COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry), Manufacturers, OEMs, Standards Developers for EN & IEC & other national standards bodies, Test Houses, Consultants, other countries regulatory bodies (i.e. FDA, Health Canada, etc.) and more.  By use of so many different stakeholders that submitted some of these and other questions this document has a much more consistent view on the implementation issues with the complexity of the topic of medical device software.  

This document is good for learning about your specific implementation issue(s) or if you have the time I would highly recommend reading the whole document, as this will help you understand the intricacies of some of the situations of implementing EN 62304 with respect to the Medical Devices Directives (I’m sure there are more issues but a good portion have been captured by this first version).  I believe this document would be of great help to implement similar guidance documents for many other national medical device regulatory agencies around the world for IEC 62304:2006 (or their national version of the standard).

The Table of Contents gives a good glimpse into the realm of the issues covered in this document and covers the following topics.  I also provide a further glimpse into the document by summarizing some of the specific issues within those sections (these are the indents furthest to the right):

• Introduction (background of the purpose, rationale, the main team members, and how to provide more feedback on the document)
• Abbreviations (Section 1)
• Questions and Answers (Section 2 – Heading of sections 2.1 – 2.7)
• Scope of EN 62304 (Section 2.1)
• Goes into various different scenarios and discusses the implication and implementation issues around these scenarios: such as SAAS, Embedded software including FPGA’s (a hotly contested issue) with single chip computers, Hardware Description Languages specifying FPGAs, Stand alone software, Medical apps, Excel macros, Open & closed systems, Internet or cloud based, Server based systems, Network devices.  In addition to this list of scenarios this section also goes into questions about certification; is Validation included in this standard & if not where does it get covered; what are the expectation of the Notified Bodies with regard to the standard; can you use only part of the standard; why do class A software to EN 62304; what is IEC 82304 about (software only products); among other questions.
• Placing Software as Medical Device on the Market (Section 2.2)
• Explain ‘placing medical device (in this case software or software {s/w} as part of a system) on the market’ in EU if EN 62304 is sufficient, by itself to do this; can I change my intended use and avoid these EU guidelines and regulations; Conformity Assessment routes of the MDD; other countries acceptance / requirement of the standard; can you sign-off on documents electronically; classification of software as a MEDICAL DEVICE; how do Notified Bodies (NB’s) confirm compliance to the standard; among other questions.
• Life-cycle Processes (Section 2.3)
• If s/w development is an outsourced activity what does NB expect; does this std have an equivalent expectation to requirements such as those addressed in FDA Part 11 (Electronic Records & Signatures) in the US; details on the review process at the end of each iteration when updated versions are available during the design and development of the software; does the std require a specific development process; how split up the requirements/responsibilities of the std between the manufacturer and s/w sub-contractor; how do the maintenance activities in the std relate to ISO 20000/ITIL; what are the artifacts (documents) required by EN 62304; at what level does the Problem Resolution Process apply; does software refactoring require a formal change request; what to include in the Technical File to show compliance with EN 62304; how can agile processes be EN 62304 compliant; among other questions.
• Risk Assessment and Risk Management (Section 2.4)
• How deal with risk control measures; when & why can the safety class of a s/w SYSTEM be reduced; how use ISO 14971 with EN 62304; explain Hazard, Cause, Sequence of Events in the context of software; when should we expect additional Software Hazard Analysis guidance within EN 62304; among other questions.
• Classification and Segregation (Section 2.5)
• What is segregation and how do I prove effective; use of a specific class(es) of s/w using COTS (commercial off-the-shelf) what criteria used; how does severity under intended use relate to s/w safety class; is s/w class optional; can you downgrade the classification of the system without a fully hardware protective system; does the compiler need to be classified under EN 62304; how are development platforms & tools related to s/w safety class; relation between Risk Analysis at System level & S/W Safety Classes; explain how the 3 safety classification in the std differ from the FDA’s 3 levels; correlate IEC 61508 SIL levels to EN 62304 safety classifications; s/w classification is a real issue with big implications; among other questions.
• Specifications, testing and tools (Section 2.6)
• I’m a manufacturer of medical devices – how do I document my requirements and tests; web-based medical s/w – does the std have specific requirements related to digital cert’s, (http or https) server requirements; in regard to the std how deal with risk analysis and functional specs; appropriate level of granularity of requirements as design input, design description; which (if any) of the tracing requirements are meant to be bi-directional; questions around deployment of the s/w; what is required of open source code from the std; among other questions.
• SOUP (Software of Unknown Provenance) and Legacy Software (Section 2.7)
• How assess & qualify suppliers of SOUP s/w, when the s/w hasn’t been developed for incorporating into a medical device; what testing & documentation does EN 62304 require for SOUP to meet the std; s/w that is either stand-alone or embedded which was designed prior to publication of EN 62304 but still being placed on the market (legacy product) – what needs to be done; if legacy s/w needs significant change, what processes & documents are required to achieve &/or maintain compliance with EN 62304 and when are changes considered significant;
• References (No Section Number – just after Section 2.7)
• Software Problem Resolution Process (Annex 1)
• Helpful diagram – There are several entry points to the problem resolution process, both during development and maintenance of the software (refer to question 2.3.12).
• SOUP selection, assessment & qualification (Annex 2)
• Flowchart & text to explain an example
• Traceability (Annex 3)
• The 3 flowcharts show an overview of the dependencies which need to be traced according to EN 62304 for all 3 classes – refer to note in bottom left corner of page to know which class the flowcharts apply to (refer to question 2.6.7).
• Position paper on direct diagnosis (COCIR, 2011) (Annex 4)
• As the different stakeholders may interpret this term differently, COCIR and EUROM VI wanted to share their understanding of the term “direct diagnosis”. (Refer to question 2.5.13)

Click on the weblink to see the initial request for questions that we posted on our website 26 May 2012.  To see the posting please go to http://www.eisnersafety.com/do-you-know-how-to-use-en62304-med-dvc-sw-life-cycle-as-implemented-under-themdd-aimdd-doc/

The EU Commission has advised that the disappearance of EN 980 was a mistake and it is still Harmonized and will be corrected at the next release of the updated Harmonized Standards Listing, hopefully in the next few months.   The EU Commission didn’t Harmonize the EN ISO 15223-1 because they saw issues in relation to the Directives (MDD, AIMDD, & IVDD) and Annex Z’s (e.g. Annex ZA, ZB, ZC) of the standard EN ISO 15223-1:2012.  Because the standard EN ISO 15223-1 wasn’t Harmonized under this last round by the EU Commission CEN extended the date of withdrawal of EN ISO 15223-1:2012 from Jan 31, ‘13 to Jul 1, ’15.

For access to the current list of Harmonized Standards, published Jan 24, ’13, they are available thru our previous post FDA & EU MDD / AIMDD / IVDD Updated Standards Lists.

Christine Ruther, an Eisner Safety Consultants Associate reminded us

“The directives already allows the use of symbols from non-harmonized standards with the stipulation that the symbols and colours must be described in the documentation supplied with the device (e.g., MDD Annex I item 13.2).  As most manufacturers define all symbols, regardless of origin, this gap in a harmonized standard for symbols should not be an issue.

In any event, manufacturers are expected to take a common sense approach to managing the situation.  This will likely entail writing a short quality plan that acknowledges the situation and defines what actions will be taken.  Actions might include waiting for the next update of harmonized standards to confirm which standards are harmonized, reviewing existing use of symbols to confirm compliance with EN ISO 15223-1 in anticipation of the change, or other actions.”  NOTE: It is not clear, at this point, if the EU Commission will Harmonize EN ISO 15223-1:2012 for the next publication of the List of Harmonized Standards for the MDD, AIMDD, & IVDD.

For Christine’s part of this post we should also thank NSAI for forwarding information on this momentary vacuum.

If you are interested in the IEC 60601 Series of Standards for Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES), this is the group that will allow you to share your experiences, ask questions and discuss your opinions. This is a platform for 60601 experts, and those that want to learn more, to discuss topics related to this large set of standards related to MEE & MES including 7 Collateral Standards (and counting) and over 60+ Particular Standards. In addition to these Particular Standards, there are many other standards that apply to MEE & MES. 

This series of standards is very important in the medical device regulatory world as the IEC 60601 series of standards are the “Gold” standard for national regulatory agencies such as the FDA, Health Canada, The EU Medical Device Directives (MDD & AIMDD), the Japanese Ministry of Health, Labour & Welfare (MHLW), and many other national regulators. Most countries adopt these standards into their national standards mostly without modification but on occasion national deviations are needed to meet the national electrical code among many other issues. 

This group is here to discuss a wide range of topics related to the IEC 60601 series of standards, the regulatory impact of these standards (such as the differences in 3rd ed. vs 2nd ed. of IEC 60601-1 & country specific regulatory impacts), the changes continually happening in this field (i.e. 3rd ed. of IEC 60601-1, IEC 60601-1, 3rd ed. + Amendment 1, etc.), what are the regulatory requirements for specific countries as they evolve (like in the Middle East & Asia), and many more topics within the medical device world are also up for play.

The group is run by Leo Eisner of Eisner Safety Consultants, an expert in the IEC 60601 series of standards, and the group is owned by IEC.  Please come and join us in this new adventure and see what you can bring to this new group and/or learn from your group members.

* NOTE:  The IEC is the owner of this LinkedIn sub-group under their main umbrella IEC LinkedIn Group.  Leo Eisner is the manager of the group and if you have any questions with regard to the IEC 60601 series of standards on Medical Electrical Equipment Sub-Group please contact Leo.

On 15 Jan ’13 the FDA issued a notice in Federal Register for the Recognition List # 30.  The notice in the Federal Register said: “FDA maintains the Agency’s current list of FDA recognized consensus standards in a searchable database…FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.”

Other resources that you can find out more about this subject:

RAPS Regulatory Focus article of 15 Jan 2013

CDRH’s Standards Program / Standards Management Staff webpage

 On 24 Jan ’13 the Official Journal of the European Union published updated lists of Harmonized Standards under their respective Directives for the:

MDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*

AIMDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*

IVDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*

* – All of the consolidated lists of Harmonized Standards have a note that indicate that these are for reference only and are not the legal documents.  A repeat of the note for these Directives is below:

“The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS (Harmonised standards) database. This IT application HAS automates the process of the publication of the references of harmonised standards in the Official Journal of the European Union. Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal affect.”

Back in April 2010 the FDA launched the Medical Device Home Use Initiative as there were concerns of the growing number of safety issues with medical devices intended for professional settings like a hospital being misused in the home setting.  An example is the misuse of infusion pumps intended for the hospital or other professional healthcare environment and not the home use environment. One of the many case studies that the FDA is publishing on a monthly basis was the case of a 9 year old girl using a insulin infusion pump set that was discarded from the hospital with an infusion pump.  Soon after using the infusion pump set she had nausea and vomiting and ended up in the emergency room.  When the medical professional removed the cannula it became apparent that it was bent and sadly the infusion pump didn’t alarm or notice the change.  The next day she died due to heart failure.  The case study on the FDA website is not clear if there is a direct connection to her death and the fact that the infusion pump didn’t alarm but you can see that the use of an infusion pump and the infusion pump set being improperly handled and maybe even the infusion pump wasn’t set-up properly caused some major issues at a minimum.

This initiative through FDA’s efforts have provided additional information and resources for manufacturers, health care professionals, home care recipients, consumers, and caregivers and FDA is continuing to develop and encourage the safe use of home use medical devices.  The key areas of this Initiative are 1) the issuance of a draft guidance document (just released and that is what this post is all about) for manufacturers recommending actions they should take to receive FDA approval or clearance of devices intended to be used in the home, 2) develop a labeling repository for medical devices that have been approved or cleared for home use (they are still working thru this issue and seeing if this will be a feasible solution), 3) Increasing Public awareness of the situation of use of medical devices outside the clinical setting.

To ensure that the FDA considers your comments on this draft guidance before the FDA begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by March 13, 2013.

The draft guidance document is a big step in the right direction as the home use environment is a very different environment than is the hospital or clinic setting where the medical devices used in those settings are controlled and operated primarily by the Dr’s, nurses or other clinicians. Whereas, outside those controlled environments (i.e. hospitals & clinics) medical devices many times are operated by a lay person (user with no professional training or experience) and so there are considerable risks that need to be considered which this FDA draft guidance document attempts to consider. The guidance document considers both OTC (over-the-counter) and prescription devices, the use environment (locations being used such as at home, in the shower, at the tennis court, out shopping, on a train or bus, on an airplane, at the beach, out for a run, etc.), and the discusses different unique risks. “The draft guidance provides recommendations for minimizing the risks associated with home use devices by considering the user, the use environment, the device or system, human factors, and labeling.” The guidance says that the recommendations apply to design and development of the device but also provides recommendations regarding postmarket considerations and lastly that the design & development recommendations should be considered even if the device that is likely to used in the home even if the device isn’t intended solely for home use.

The guidance does differ from IEC 60601-1-11 (medical electrical devices for use in the home use environment) a bit in the definitions as the guidance says that:

A home use device is a medical device intended for users in any environment outside of a professional healthcare facility or clinical laboratory. The term includes devices intended for use in both professional healthcare facilities and homes.

A professional healthcare facility is an environment where operators with medical training are continually available to use devices when patients are present. This includes but is not limited to hospitals, long-term care facilities, nursing homes, emergency medical services, clinics, and outpatient treatment facilities.

A qualified healthcare professional is a licensed or non-licensed healthcare professional with sufficient skills and experience with the use of a device to aid or train someone to use and maintain the device.

A home is any environment other than a professional healthcare facility or clinical laboratory where a device may be used.

Whereas, in the IEC 60601-1-11:2010 standard the following definitions mean that the Nursing Homes are considered to be a Home Healthcare Environment which is in conflict of the FDA draft guidance document which doesn’t include it in their definition as a “Home Use” Environment.

Home Healthcare Environment (clause 3.2) is a dwelling place in which a Patient lives or other places where Patients are present, excluding professional healthcare facility environments where Operators with medical training are continually available when Patients are present

Within this same definition (clause 3.2 of IEC 60601-1-11) there are a couple notes that clearly state what a Professional Healthcare Facility is including environments such as a hospital, clinic, Dr’s offices, free standing surgi-centers, dentist offices, free standing birthing centers BUT doesn’t include Nursing Homes as a Professional Healthcare Facility.  This is where the FDA guidance document and IEC 60601-1-11 differ and this is surprising to me as the FDA guidance document does refer directly to IEC 60601-1-11 in seven cases in the guidance document so they are relying on it for some of the basis of the guidance document.

Design controls are called out in several ways in the guidance document including use of Design Controls per 21CFR820.30 which if you have an FDA QS (Quality System) per the QSR (Quality System Regulation) this should be included in your QS if you design products.  Also, it discusses as part of the Design Controls the use of the Risk Management Process per ISO 14971 with some additional inputs to the risk management process including from Human Factors / Usability Engineering Analysis per AAMI HE74 (Human Factors Design Process for Medical Devices), AAMI HE 75 (Human Factors Engineering – Design of Medical Devices), and IEC 62366 (Application of usability engineering to medical devices).  Lastly, this section of the guidance also discusses that software should be controlled thru the Design Control process and that IEC 62304 (medical device software – Software lifecycle processes) as well a couple FDA Guidance documents on Software are important to consider, as applicable to your home use device.  This means that you, the manufacturer, will need to per the FDA guidance document “broaden your existing concept development and preliminary testing processes to account for the needs of home users and requirements for straightforward device operation, obvious interface layouts, and appropriate alarm methods.”  As you can see Design Controls will be important to follow the FDA Recognized Consensus Standards (ISO 14971, IEC 62366, IEC 62304, & AAMI HE75 but HE74 isn’t an FDA Recognized Consensus Standard) and the applicable FDA Guidance documents, as well.

Now, let’s look at Environmental Considerations a bit more – As I mentioned earlier in this post there are many locations to consider.  The guidance document in section 3, “Environmental Considerations”, refers the reader directly to IEC 60601-1-11:2010 (1st edition), it also indicates that you should label the device to include warnings against using the device in environmental conditions which would raise safety & effectiveness concerns but never label to mitigate risks (very similar tone as from the EU Commission in regard to all 3 Medical Device Directives). The main environmental considerations this section of the document covers the following environmental considerations:

•  Location – Such as urban, suburban, rural, school, office, retail, trains, planes, cars.   How does the applicable environments to your device impacts the patient, the device,  and the environment around the device?  What’s the impact on the device from Electromagnetic Interference (EMI)?
• Physical Location – Consider the structure of the location(s) the device will be used in. What about a crowed location such as a small apartment with lots of stuff around that the patient may bump into on a regular basis?  Are there any hazards because of the crowded environment, such as tripping hazards, device cables getting tangled, device getting bumped, etc.
• Contaminants – Consider the environment a non-sterile location.  Consider the risks that your device or the location of it’s use could be contaminated with such things as smoke, pet hair, household chemicals, etc. Design the product to prevent ingress of liquids and particulates.  Refer to IEC 60601-1-11 as these are some of the considerations within the standard.
• Water supply, if applicable to the device – type of water – distilled vs well or tap water – An example would be the impact if a CPAP machine used tap water vs distilled water there is a lot of mineral deposits that end up on the water chamber which means some of that could be breathed in by the patient.  So, is this a hazard?  Something for the manufacturers to figure out.
• Temperature – There could be a variation in temperature within a home that doesn’t have air conditioning, what if the device is portable and left in the car on a really hot day or on a snowy day?
• Dampness & humidity – Similar considerations to Temperature.
• Atmospheric pressure changes –  Elevation and plane travel have impact on this issue.
• Air-flow – Blocked air vent can be an issue in this case if your device relies on ait-flow.
• Child-proofing – Since the device will be in the home and many homes have children or children visitors the devices should be child-proofed (avoid small parts being accessible, minimize number of detachable parts, etc.).
• Tamper-proof – Intentional and no-intentional.
• Travel & International Use – Local, regional, international.  This means change in power source voltage, current & frequency are all possible which could have impact on the functioning of the device.  There could be need for a battery back-up and labeling to deal with identifying what power adaptor would be sufficient to work for what country of use.  Some countries such as Japan depending on what part of the country you are located in you have either 50 or 60 Hz, but only 100Volts (differs from the typical 120 VAC in the US).  Interpower Corp has a great resource if you are looking to know what is the voltage and frequency for each country and also the power plug type.  This chart by Interpower is something I refer to on occasion but I can see many of my clients using this document.
  Also, consider traveller passing thru security checkpoints and how that impacts the patient of body-worn devices and the impact of the x-ray or other screening technologies (now and in the future) impact on the device itself. Or if the user must under go a “pat-down” The guidance points the user of this guidance to the TSA website for information to consider being added to the user’s manual.
• Fluid Exposure – Fluid spills and submersion of fluids.  This is also considered in IEC 60601-1-11.

The guidance goes on to “User Considerations” for section 4 of the document.  The user in this case is not the same as the Health Care professional that uses devices in the hospital, clinic, dr’s office, out-patient surgi-center, nursing home, and other professional health care facility.  Home users can have a wide range of disabilities that the device maker will need to consider in the design of the device including physical, sensory/perceptual, cognitive, emotional capabilities and disabilities.  So, you need to make the device as easy as possible as can be used and you need to consider and use some if not all of the documents that FDA recommends in this section which includes: FDA guidance on Human Factors (issued july 2000 – dated compared to the next few standards noted here), IEC 62366:2007, AAMI HE75:2009, IEC 60601-1-11:2010.

Section 5 goes into “Device Considerations” which the FDA means to keep it simple (or the KISS concept – Keep It Simple Stupid) to understand, operate, and maintain safely & effectively.  FDA provides some device – specific considerations that the device maker should consider in their design and development of the device(s) at hand such as:

• Lock-out mechanisms – to avoid access to certain functions that the health care provider may need to set.
• Calibration – avoid calibration if possible and if not minimal calibration by the user (make sure to have very clear step by step instructions & clear feedback while doing any calibration steps).
• Mechanical Strength – Refer to IEC 60601-1-11 for mechanical tests of both transit operable and non-transit operable devices.
• Electrical Issues – Supply mains (power source tests per IEC 60601-1 – interruption, voltage limitations); Internal electrical power source (i.e. batteries – charging issues, IFU details, replaceable batteries); Permanently installed devices (grounding issues); Outlets and Adaptors (can the device share power with another device?, can you connect device to an outlet that is connected to a switch?, etc.); Power outages (back-up power considerations, emergency contact info, how long or how many cycles can the device operate without mains power?, etc.); Battery life (how long operate on a fully charged battery?)
• EMC (Electro-magnetic compatibility) – Refer to the FDA Recognized Consensus Standard IEC 60601-1-2:2007 Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests.  This standard considers tests for immunity of the device to the outside world and emissions from the device to the outside (it’s impact on other things and devices).
• Wireless Technology – Manufacturer will need to meet applicable technology standards (none mentioned in the document), FCC requirements.  Safety & effectiveness concerns of the wireless technology will be an important point to highlight and prove to the FDA.
• Alarm Systems – FDA recommends to follow IEC 60601-1-8:2006 (2nd edition) – Medical electrical equipment; Part 1-8: General requirements for basic safety and essential performance; Collateral Standard: General requirements, tests and guidance for alarm systems in medial electrical equipment and medical electrical systems.

Section six discusses “Human Factors” including User Training, Certification and the FDA guidance documents and standards such as ISO 14971:2007 (Risk Management for Medical Devices), IEC 62366:2007 (mentioned earlier in this post) and AAMI HE75:2009 (mentioned earlier in the post).

Section seven discusses “Labeling” at length including the FDA requirements under 21CFR Part 801 (Labeling) & 809.10 (Labeling for in vitro diagnostic products); FDA guidance document on Patient Labeling (Issued April 2001); 6 other FDA guidance documents; IEC 60601-1-11:2010, section 7.5.2; ISO 15197 First edition 2003-05-01, In vitro diagnostic test systems – Requirements for blood-glucose monitoring system for self-testing in managing diabetes mellitus, Clause 5; a booklet that FDA put together for the Home User of the Device – titled “How to Prepare for and Handle Power Outages for Medical Devices that Require Electricity”; a reference to the Department of Homeland Security for “Prepare for Emergencies Now”;  the FDA webpage titled “FDA Offers Tips about Medical Devices and Hurricane Disasters”; a reference to the EPA (Environmental Protection Agency) website in how to properly dispose of medical waste focused on state programs and regulations;  and references to IEC 60601-1-2:2007.  I am disappointed the guidance doesn’t refer to other sections of IEC 60601-1-11:2010 as there are other important areas to consider for marking & labeling from both IEC 60601-1:2005 (or AAMI ES 60601-1:2005) in clause 7 and also in IEC 60601-1-11:2010 in clause 7.

Section 8 goes into “Postmarket Considerations” including Customer Service, Medical Device Reporting and Selling or Purchasing Used Prescription Devices.

Section 9 is the conclusion section of the document pointing at that if you follow this document in the design and development of your device you have a higher likelihood of a safe and effective device.

Section 10 is a listing of additional resources to consider while you are on this journey of designing a safe and effective home use device.