Essential Performance (EP) initially came into the IEC 60601 series of standards when the 3rd edition of IEC 60601-1:2005 was published. The definition was quite confusing and many manufacturers, regulators and test houses had a hard time with it and how to apply it properly. In 3rd edition (2005) + amendment 1 (2012) some clarification came into play which made it easier to understand but there is still a fair amount of confusion.

About 2 years ago a test lab did some research and brought up the issue that a significant number of test reports (a high percentage of them) of critical devices didn’t define essential performance appropriately to the Sub Committee SC62A on “Common aspects of electrical equipment used in medical practice”. From this research, an ad-hoc group was formed to come up with a solution.

The initial solution was to come up with this Interpretation Sheet (ISH) to explain Essential Performance (clause 4.3 which is not as clear as the ISH but for those that know the standard have been doing it this way for years) and Single Fault Condition (SFC) (clause 4.7) that is related to Essential Performance. Access a copy thru the IEC website if you know where to find it or the easier route is to download it here. Note, this document doesn’t cover all the issues about Essential Performance as it is a complex situation but it does help explain some of the issues involved. The ISH per IEC requirements is limited to 2 pages of written text of explanation allowed by IEC requirements and so has a constraint on how detailed it can get. It is good for explaining the concept for the General standard IEC 60601-1, edition 3.1 which covers also ed. 3.2 (no change there). The General standard concept is based on limits but for some Particular standards (IEC 60601-2-XX or IEC/ISO80601-2-XX), limits don’t work for all products applicable (not all display-based product that the clinical function is based on the display function for example). But the ISH doesn’t really get into the details of how EP deals with Particular standards much (covered a little in the ISH) so that really needs to be looked at further still.

So, what is the next step? This ad-hoc group with the help of some additional people in the standards development community (I hope to be in this group) will start in the next couple of months (probably after the IEC TC 62 General meeting of April 12 – 23, 2021) to work on a guidance document to provide further guidance on EP as I still find that many regulators around the world, test labs, and manufacturers all have varying understanding of what EP & SFC are.

This varying understanding has a huge impact on projects as if say the test lab asks the manufacturer what their EP is, the manufacturer may say I don’t have any, the test lab will check the test report form (TRF) as none. When gets to say FDA the first thing FDA would ask is why is there no EP on the device? If found out there is EP the client would have to retest under the applicable IEC 60601-1, Particular (60601-2-XX/80601-2-XX) and Collateral Standards (60601-1-XX) + the EM Disturbances standard IEC 60601-1-2 which would add cost and time delays to a project.

Need help with Essential Performance. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at Leo@EisnerSafety.com.

Just Published on 23 Sept 2015 the Australian / New Zealand Joint Standard AS/NZS IEC 60601.1:2015 which is based on the complete IEC 60601-1, edition 3.1:2012 (identical).  The only differences are in the AS/NZS IEC 60601-1:2015 the preface states to a) replace the international standards references with references to Australian or Australian / New Zealand Standards, b) replace in the source text ‘this international standard’ by ‘this Australian/New Zeland Standard’, c) a full point substitues for a comma when refeering to a decimal marker.

If you need help with AS/NZS IEC 60601-1:2015 or IEC 60601-1, 3rd edition or edition 3.1 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).

Reminder post – withdrawal of CAN/CSA C22.2 No. 601.1-M90+A1+A2 is on June 30, 2014 & CAN/CSA-C22.2 No. 60601-1:14 was recently published

Withdrawal of CAN/CSA C22.2 No. 601.1-M90+A1+A2

After June 30, 2014 you will no longer be able to use CAN/CSA C22.2 No. 601.1-M90+A1+A2 for a Canadian Certification Project and it will be replaced by use of either CAN/CSA C22.2 No 60601-1:08 (equivalent to 3rd edition of IEC 60601-1with Canadian National Deviations) or CAN/CSA C22.2 No. 60601-1:14 (equivalent of IEC 60601-1, 3rd edition + A1 + Canadian National Deviations).

Recently Released CAN/CSA C22.2 No. 60601-1:14

CAN/CSA C22.2 No. 60601-1:14 was published a couple months ago and is still not added into Health Canada’s List of Recognized Standards.  Per our associate Christine Ruther recently indicated that “Health Canada…is open to receiving submissions that reference A1.  If A1 is applied, Health Canada would appreciate a gap analysis to identify where the differences in the versions might impact the safety and effectiveness of the device to aid the person reviewing the file.  (Such an analysis can be readily created.)”  This gap assessment should be conducted between the currently Recognized standard such as CAN/CSA C22.2 No 60601-1:08 against the CAN/CSA C22.2 No. 60601-1:14.

More details about these two subjects are noted in the below links that have been previously posted on our site:

CSA C22.2 No.601.1-M90 Medical Electrical Equipment Standard Withdrawal Notice

CAN/CSA C22.2 No. 60601-1:14 (Harmonized with Ed. 3.1) Recently Released

If you need additional support for IEC or CAN/CSA C22.2 No. 60601-1, 3rd edition + A1 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).

This blog reviews the release of Canadian Standard CAN/CSA C22.2 No. 60601-1:14 & where accessible (Safety Test Agencies vs Health Canada)

Recently Released CAN/CSA C22.2 No. 60601-1:14

Good news!! Canada has recently released CAN/CSA C22.2 No. 60601-1:14 (:14 = 2014 year of release) which is their aligned Canadian National version of IEC 60601-1:2005 (3rd ed.) + Amendment 1:2012 (also known as IEC 60601-1, edition 3.1).  Standards Council of Canada’s (SCC) listing of this standard is titled: “CAN/CSA C22.2 NO. 60601-1:14 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (Adopted IEC 60601-1:2005, third edition, 2005-12, including amendment 1:2012, with Canadian deviations)”.  The SCC website for this standards points to 3 sources for obtaining the standard.  CSA Group, TechStreet, and StandardsStore.ca.  The standard is 1062 pages long because Canada requires English and French. CAN/CSA C22.2 No. 60601-1:2014 replaces CAN/CSA-C22.2 NO. 60601-1:08 (R2013) or CAN/CSA-C22.2 NO. 60601-1:08.  I have been advised that the National Deviations in this version of the standard should be very similar to CAN/CSA-C22.2 NO. 60601-1:08.

As of March 1, 2014 Canada is now accepting edition 3.1 with National Deviations under CAN/CSA C22.2 No. 60601-1:14.  I have been advised by CSA and a couple other Safety Test Agencies that they are starting to test to this standard.  Note that Health Canada has not updated their list of Recognized Standards for Medical Devices since Oct 2013 and so this standard is not in their current list of standards.  Currently Health Canada’s list only includes the 3rd ed. of IEC & CAN/CSA which on the list is either IEC 60601-1:2005 + Corrigendum 1: 2006 + Corr. 2:2007 or CAN/CSA-C22.2 NO. 60601-1:08.  I am sure you will be able to use this newer version of the standard for Health Canada submissions but I would check with your reviewer from Health Canada if you are submitting using this version of the standard what they may expect.  They may ask for a comparison between 3rd edition and ed. 3.1.  I would assume in their next update of the List of Recognized Standards Listing they will add this standard.

As with all the changes in standards I am asked when will each country and Safety Test Agency require the newer version of the standard and when will the older version be phased out.  At this point there are no firm dates and I will advise as soon as I find out more information on the subject.

If you need help with working with a Safety Test Lab to get a Certification to IEC 60601-1 or National Versions of the Standard, 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).

To kick-off the morning for our track I will be talking briefly on a draft document that NB-MED & COCIR & some other organizations are working on to help clarify what is expected of medical device manufacturers when relying on EN ISO 14971:2012 which is a document that has totally muddied the waters.

I am in direct contact with the authors of this consensus based document and we are working on finalizing what I will be presenting to you at the conference. So, expect some up to the date information about this document and we may be asking for feedback from industry too.  Stay tuned for any updates to this post too.  I look forward to presenting this material to the conference participants.

If you need help with the Risk Management File concepts within the IEC 60601 series of Standards, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

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.

A1 addresses 182 issues that have been identified by various interested parties starting prior to the end of the development process of IEC 60601-1, 3rd edition which was published December 2005.  The initial comments that were brought into the A1 project were initiated during the FDIS (Final Draft International Standard) stage of IEC 60601-1, 3rd edition.   Through the A1 process there have been 496 separate changes made to the standard (third edition).  There is a potential Technical Report document that is being discussed and voted on by the National Committees for IEC SC 62A the sub-committee on ‘Common aspects of electrical equipment used in medical practice’, which is in charge of the standard IEC 60601-1 among other standards and technical reports in the IEC 60601-1 series.  This document, if approved, will help users of A1 in assessing the impact of the most significant changes to A1:2012.   In this draft Technical Report state it has identified 83 changes of moderate or significant impact on the user of the standard.  In its’ present state the draft Technical Report also breaks up the impact analysis of the changes into Impact on ‘Many Users’ vs ‘Particular Users’ (a smaller subset of ‘Users’ of the standard).  As this draft Technical Report develops more news will be issued.

If you have any questions in regard to IEC 60601-1 and it’s series of Standards and Technical Reports Eisner Safety Consultants is here to support you in your efforts of meeting and maintaining compliance with applicable Standards.  Please feel free to contact us at Leo@EisnerSafety.com.

On October 1, 2011 the DRAFT “FAQ related to Implementation of EN 60601-1:2006 Clarification of open issues” was issued and this DRAFT document is being sent to NB-MED for commenting on the document.  NB-MED is also known as TEAM NB.  This organization is the European Association of Notified Bodies for Medical Devices which covers the MDD (93/42/EEC), AIMDD (90/385/EEC), and IVDD (98/79/EC).  This group publishes guidances that are agreed on by the Medical Device Directives (93/42/EEC, 90/385/EEC, and 98/79/EC) Notified Bodies. Once all the responses are agreed to it is anticipated that the document will be released as an NB-MED guidance document.

The History of this DRAFT document is restated below.  Note that any “click here” links are not live in the below text but are live in the actual DRAFT document.

History

During spring 2011, it was realized that the use of EN 60601-1 and its many family members in demonstrating compliance with the relevant and applicable requirements of the European medical device regulatory framework was not too trivial. While relevant guidance on the matter had been published at the CENELEC website as a Q&A document (click here), some Notified Bodies were giving advice that was felt to be not in line with that guidance. On other occasions, questions were raised that were not covered in the guidance.

So, it was concluded that the situation for electrical equipment in medical practice was not totally clear and that additional guidance would be useful. Further contact with the chair of the NB-MED confirmed this desirability, and a small group of experts was established. This group developed an enquiry asking for “practical issues in the implementation”, that was sent to many stakeholders in June 2011(see Annex 1). Also at the international level of IEC the request was distributed (62A/769/INF).

The response to the request was beyond expectation and the small team of experts, initially consisting of three, was expanded with Dr. Klaus Neuder of DKE (Frankfurt, Germany).

End of July 2011, the work on digesting the issues submitted until then started and it took until end of September 2011 until all material had been thoroughly discussed and answers formulated to the questions that were raised. In some cases, the questions were slightly amended to make them a little more general, and a few additional “connecting” questions were developed by the team.

It is believed that the answers, developed in close team cooperation, present a fair response to the issues brought forward and that they can be used as a reference for all stakeholders.

Now it is time for the NB-MED to scrutinize the proposed responses and see if they are also acceptable to all members of NB-MED. The NB-MED comments are kindly awaited by the end of October 2011, at the same e-mail address that was used for the initial submission of the issues: 60601Ed3.NBMED.issues@gmail.com, using the form supplied together with this document.

Happy reading!

The 60601-1 Issues Team:

Dr. Wolfgang Leetz, Dr. Peter Linders Dr. Klaus Neuder Mr. Martin Schneeberg