Big News!!!

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

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

From what I have determined the change in transition date is based on that OSHA’s NRTL (Nationally Recognized Test Laboratories) Program will be aligning with the FDA in terms of this standard and will hopefully be by the end of this year, if not sooner, they will be able to approve NRTL Test Labs to the US National Version of IEC 60601-1, 3^rd ed. which probably will be ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text).  FDA has been intending to, and I hope they do, come out with a guidance document for premarket submissions of medical electrical equipment and what their expectations are for applying the US National Version of IEC 60601-1, 3^rd edition.  Also, about 1-1/2 months ago FDA announced their concern about cyber-security for medical devices and hospital networks and so they issued a Safety Communication on June 13, 2013 to medical device manufacturers, hospitals, medical device user facilities, health care IT & procurements staff; & biomedical engineers; and they issued a draft guidance document on the issue on June 14, 2013.  To coordinate all these activities, draft guidance documents, and agencies FDA decided to extend the transition period for the US National version of IEC 60601-1, 3^rd ed. equivalent.

The IEC 60601 series of standards that FDA has Listed in the Recognized Consensus Standards Listing and some of the ISO 80601 series of standards that FDA has listed are updated in List 031 with this new transition date, unless it is a brand new standard being published on the List for the first time, along with other changes that were ready to be published.  The Cyber-security standards are listed in Recognition List 032 and are all new listings to the List of Recognized Consensus Standards.  There were many other changes with these Recognition Lists 031 & 032 which will officially be published in the Federal Register as of 6 August 2013 and the changes will officially be effective then but have already been issued prior to August 6, 2013 in the FDA’s Recognized Consensus Database. (Either one or two days prior).

Below is a summary of the more critical changes, from my perspective, for List 031.

New Standards Added to the FDA’s Recognition List 031 (Table 2 of List 031) of significance are:

There were also modifications to the List of Recognized Stds (Table 1 of List 031) of some importance.  The 60601 related standards were updated to align with the transition period of ANSI/AAMI ES60601-1 std along with other changes of importance as noted below.

In a future blog post we may discuss Recognition List 032 and the Cyber-security standards.

If you have any questions or if you would like our assistance with regard to these standards please feel free to contact us at Leo@EisnerSafety.com.

Introduction of IEC 60601-1 (third edition) with amendments

They will be requiring that for electrical medical devices these products will need to meet IEC 60601-1, 3^rd ed. (2005) + Amendments*.   This requirement is effective for Class 3 & 4 medical devices as of June 1 2014, for Class 2 medical devices as of June 1 2015 and lastly for Class 1 medical devices as of June 1 2016.

* Depending on what this Amendment to the Medical Devices Act consider Amendments it could be just Amendments of the standard or it could include & probably should consider the Corrigendums and Interpretation Sheets too.   All the possible current Amendments are Amendment 1:2012 + Corrigendums 1:2006 and 2:2007 for 3^rd ed. and Corrigendum 1:2012 for ed. 3.1 + Interpretation Sheets 1:2008, 2:2009, & 3:2013.

The notice also states that MFDS will lay down new safety standards for software as medical electrical equipments.  My guess is that they will require complying with IEC 62304 which is the standard for Medical Device Software Lifecycles as it has become very popular around the world for many national regulatory bodies.  We will have to wait and see what happens for this requirement, as the notice is not clear as to what standard(s) they will use as of now.

Introduction of the Summary Technical Documentation (STED)

As of January 1 2014 Class 4 medical device applicants (except for IVD reagents) will be required to submit in the the STED format.  MFDS says that this will expedite the review timelines for the manufacturers and devices that are submitted.  Class 1, 2, & 3 devices have the option of submitting in the STED format as of the date for the notification.

Revised “Regulations on Classification and Grades”

MFDS announced several changes for the regulations on classification and grades covering the following issues:

• 94 new products are added under “cell manipulating kit for medical use”.
• Definitions for 108 products have changed including for “heater systems”.
• The Class of “dental color measuring devices” was down-classified to Class 1.
• 67 commercial names including “warm bath equipment” are edited out.
• The changes are effective as of the date of notification.

We also set-up pages to do the same for checking on the status of the IEC 80601 series of current & draft standards, which are standards that are jointly developed between IEC & ISO, and TRFs of the current 806012 series standards.  These later standards are called either IEC 80601-X-Y standards or ISO 80601-X-Y standards.  The lead organization gets their organization initials in the standards identifier.

This is a great resource to be able to stay up to date on the standards that are being developed, the updates to current standards and to ensure your standards library is up to date as required under ISO 13485 and also under most medical device regulatory national schemes.  If your organization needs help keeping track of current &/or developing standards our organization can help you develop a system or we can do this work for your organization’s standards and external documents library.  Please feel free to contact us about this at Leo@EisnerSafety.com or 503-244-6151.

In Addition to this article I have blogged on the topic a couple other times so if you want to see more material (original post) on the topic please continue to read on more of the details and experiences that impact many different people in many different ways (some good and some not so good) on the use of Medical Devices in the Home Use environment and how that impacts the users and their families that use these old and new technologies in the home.  Sometime these devices really are only designed for the hospital setting like some IV pumps, patients may have trouble with them to the point that patients pass away, which is a real tragedy no matter how you look at it.  There are 2 MD&DI articles on the Home Use Draft Guidance and one of the articles deals with an IV pump that probably shouldn’t have been in the home use environment with really sad results.

If you company needs support dealing with the IEC 60601-1-11 standard for Home Use Environment or with the FDA Home Use Draft Guidance document, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval we can provide you with regulatory, product safety, standards compliance, quality system services and more.  Please feel free to contact us at Leo@EisnerSafetty.com or 503-244-6151.   

The end of the transition period for 2^nd ed. of IEC 60601-1 is June 30, 2013.  By July 1, 2013 I hope you will be using the 3^rd ed. based standard for your FDA premarket submissions declarations of conformity.  Are you ready for this transition period and where is the transition information located?

The answer is that the IEC version of 60601-1 isn’t a Recognized Consensus standard after the end of the transition period for 2^nd ed. of IEC 60601-1.  FDA will allow the 2nd ed. of IEC 60601-1:1988 + A1: 1991 + A2:95 (Recognition Number 5-4, Recognition List #013) up til the end of the transition period of June 30, 2013 but the transition period isn’t noted in this entry of the Recognized Consensus Standards list.  So, where do you suppose it is located?  One could search for a very long time and not come up with the answer, as the FDA database for Recognized Consensus Standards is not flexible when it comes to search terms.  You need to know to search for the US national version of the standard, which is the AAMI ES version.  Also, the entries for the 3^rd ed based US national version of IEC 60601-1 vs. the 3^rd ed. + A1 national version of IEC 60601-1 aren’t in the database the same way.  One is in the database as ‘ES60601-1’ and the other is ‘ES 60601-1’.

So, as of now you can start to use the ANSI/AAMI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012, including the A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment – Part 1: General requirements for basic safety and essential performance [Recognition Number 5-71, Recognition List #029] OR ANSI/AAMI ES 60601-1:2005/A1:2012 [Recognition Number 5-74, Recognition List #030] Recognition list #030 was issued on 15 Jan ’13.  Up to and thru June 30, 2013 you can also use the 2^nd ed. of IEC 60601-1 [Recognition Number 5-4, Recognition List #013].  In the Extent of Recognition section of both ES 60601-1 standards you will find a sub-section titled “Transition:” which states:

“FDA recognition of Edition 2:1988 (A1:1991+A2:1995) of IEC 60601-1 is hereby superseded by recognition of ANSI/AAMI ES60601-1:2005, Medical Electrical Equipment – Part 1: General requirements
for basic safety and essential performance. FDA will accept declarations of conformity, in support of premarket submissions, to Edition 2:1988 (A1:1991+A2:1995) of IEC 60601-1 until June 30, 2013. After this transitional period, declarations of conformity to Edition 2:1988(A1:1991+A2:1995) of the standard will not be accepted.”
Note, the text of the transition for both of the ES 60601-1 standards is the same.

If you company needs support dealing with the IEC 60601 series of standards, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval we can provide you with regulatory, product safety, standards compliance, quality system services and more.  Please feel free to contact us at Leo@EisnerSafetty.com or 503-244-6151.   

Buyer Beware – Nursing Home Use Issue:

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

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

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

MD&DI Articles:

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

Related Articles:

FDA on Quest to Standardize Mandatory MedDvc Labeling

FDA Issues Draft Guidance on MedDvcs Intended for Home Use

Two industry leaders in the development of IEC 60601-1, 3rd ed. A1 answer some really good questions such as: Why changes to Risk Management & Essential Performance, What else changed in the standard, and What makes A1 unique.  This article is part of AAMINews letter for Jan 2013.  

As I just read part of a TÜV SÜD E-ssentials e-newsletter – Sept 2012 – I answered the question.  Note, that this question doesn’t ask about Harmonization under the MDD. Note, additional blog posts on Amendment 1 (or A1:12) including A1 of IEC 60601-1:05 (3rd ed.) has been published by IEC (on 13 JUL 2012), IEC 60601-1:12 Consolidated 3.1 ed. Just Published (on 23 AUG 2012), and Update Notice on IEC 60601-1:12 Consolidated 3.1 ed. (on 18 Oct 2012)

“By the TÜV SÜD essentials newsletter Sept 2012 says ‘Experts expect the…A1-EN standard to be published in January 2013.’ Realize this is only an estimate but it does fit within the CENELEC website information which is below:

If you read the cenelec webpage http://www.cenelec.eu/dyn/www/f?p=104:110:2544538240073882::::FSP_ORG_ID,FSP_PROJECT,FSP_LANG_ID:68,23401,25# it sounds like between 17 Nov 2012 (date of announcement = doa) to 17 May 2013 (date of publication = dop) is when the EN version of the standard would be released to the Europan Market place but this may or may not be the same time as when it is Harmonized under the MDD & AIMDD. For the definitions of doa & dop please refer to the lower right hand side of this webpage which gives you these definitions. Also, note that the stage code (or can be said as a progress stage code of the project) is 5091 which means that formal approval will occur but a “decision on voting results (is) deferred (and) advice (is) expected.”

You don’t have to leave your office to join in on the presentation and as a special thank you for visiting us at Eisner Safety Consultants you can get a 20% discount.  To find out more about the presentation & discount just click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.