Medical Electrical Standards are constantly being changed and evolving and the amount of changes seems to be accelerating. All too often I hear clients complain that they didn’t know about a standard until way too late in the process and have had to redesign their product to meet regulatory requirements.

So how do you stay up-to-date on all these changes? Are you considering the implication of these standards when putting together your regulatory strategy? Do you know what standards are coming down the line and how they may impact your product design? Are these standards harmonized in different markets? Does your test lab always know what versions of standards you need to test too?

If you have a medical electrical device or a software as a medical device and your answer to any one or more of these questions is NO then this free 90 minute webinar is for you.

Take Aways from this Webinar:

• What medical electrical and related standards are being updated now and how they interact with each other.
• What is the schedule for the IEC 60601 Amendment Projects and what other standards (i.e. ISO 14971, IEC 62366-1, IEC 62304) will impact the project?
• Overview of the recently released Wireless Coexistence Standards for US.
• Why you may need to redesign your product to meet the EMC Standard IEC 60601-1-2:2014 (4th Ed.).
• How does testing under the CB Scheme impact your testing and regulatory strategies?
• Resources to keep track of standards from both a regulatory and standards development perspective

WHO SHOULD ATTEND?

• Medical Device Executives
• QA/RA Professionals at all levels
• Compliance Engineers
• Quality Engineers
• Design Engineers
• Project Management Engineers
• Senior Staff involved in management reviews per ISO 13485 for the standards update section

If you want to learn more about the IEC 60601-1 certification process you can read an article on the greenlight.guru blog of a presentation I gave awhile back on this process.

ABOUT THE PRESENTER:

This webinar is being lead by me (Leo Eisner), “The 60601-1 Guy”, founder and principal consultant at Eisner Safety Consultants and moderated by Jon Speer of greenlight guru.

Leo is a licensed professional engineer in safety engineering, a certified Quality System lead auditor, an expert in product safety for medical electrical devices (IEC 60601 series of standards) and an expert in CE marking for the medical device EU Directives.

Eisner Safety Consultants has helped countless clients thru the Product Safety and Regulatory maze over the 20 year history of the company. Leo has 30 years experience in product safety. Leo ran the Compliance Engineering Group at Karl Storz and was a Senior Product Safety engineer at TÜV Product Service.

Speed your time to market by following the step-by-step instructions that I will discuss in this free, 90 minute webinar, so you can obtain your product certification to IEC 60601-1 series of standards quicker.

I will walk you through the steps to success for product testing by a certification agency (like UL, TÜV, BSI, Intertek, etc.) to the IEC 60601-1 series of standards on medical electrical equipment and systems.
Learn from the expert the mistakes others have made that have slowed down their certification process (and how you can avoid them).
Take proactive steps so your product doesn’t need to get redesigned after testing starts.

Take Aways from this Webinar:

• The IEC 60601-1 standards series & if they apply to your product.
• What you need to know to classify your products to the IEC 60601-1 series.
• What is an isolation diagram and how does that help me with my design?
• Understanding the importance of the Risk Management File and Essential Performance requirements.
• Determine the applicable tests for your device.
• What are the marking and labeling requirements for the device?
• Know your critical components.
• What pre-tests to run and what’s not worth testing?
• What samples are needed for testing?
• Resources to help with this process and ways to reduce the paperwork off your backs.  Get your free sample of Our Annual Standards Trends Report. Learn more about our Annual Standards Trends Report service.

If you want to get a prelude to this webinar listen to the podcast that discusses some of the Take Aways of this presentation.

About the presenter:

This webinar is being lead by Leonard “The 60601-1 Guy” Eisner, founder and principal consultant at Eisner Safety Consultants.

Leo is a licensed professional engineer in safety engineering, a certified Quality System lead auditor, an expert in product safety for medical electrical devices (IEC 60601 series of standards) and an expert in CE marking for the medical device EU Directives.

Leo has helped countless clients thru the Product Safety and Regulatory maze over his career. He has 30 years experience in product safety. Leo ran the Compliance Engineering Group at Karl Storz Imaging and was a Senior Product Safety engineer at TÜV Product Service. Prior to that Leo worked in a cross section of groups at U.L. for 9 years.

About greenlight.guru

greenlight.guru is the only Quality Management Software built exclusively for the unique needs of medical device companies, allowing you to bring safer devices to market faster while reducing risk and ensuring compliance. Visit their home page to learn more.

About Eisner Safety Consultants

Eisner Safety Consultants provides affordable, on-time product approvals via safety & regulatory agencies to medical device companies. We provide assistance with U.S., Canadian, European, & other international regulations. Click here to learn more about our services we offer.

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).

The old MDD Harmonized Standards Listing used to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived.  The new site can be found by following the instructions on the archived site.  First click on the link in the bright yellow band on the top of the old site titled “Internal Market, Industry, Entrepreneurship and SMEs website“, then on the new page that opens click on the “Single Market and Standards” link, then on the left hand bar select the link titled “European Standards“, then on the next web page select the link on the left hand bar titled “Harmonised Standards“. Then search for the section titled “Healthcare engineering” and select the applicable medical device directive you are looking for:

• Medical devices (MDD)
• Active implantable medical devices (AIMDD)
• In vitro diagnostic medical devices (IVDD)

If you need help with your EU CE for the Mark Medical Device Directive, the Active Implantable Medical Device Directive or the IVD Directive, 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). 

The standard IEC 60601-2-52 is at the 1st edition + Amendment 1 as an FDIS.  The voting period is from 12 December 2014 thru 13 February 2015.  It should be published as an IS if the vote is positive shortly after (forecasted to be published on 27 March 2015).

A1 changes include:

• Added definition of sub-clause 201.3.219 of an Adult and appropriate places through out the standard.  Note the definition of an adults in this standard is at least 146 cm (57.48 inches  = 4 ft & 9.48 inches) in length, at least a mass of 40 kg (88.18 lbs), and a body mass index of at least 17 (this is on the upper end of the under weight category but goes up to the high end of obese > 40 bmi).
• Added a requirement that hazards related to Patients taller than 185 cm should be considered in the Risk Management. (Sub-clause 201.4.2)
• Updated the Entrapment test tool of figure 201.103a) & b).
• Added a new symbol required to mark on a medical bed to identify what the requirements for the “adult” using the medical bed are.  (Sub-clause 201.7.2.2.107) The symbol is to be placed on the medical bed in a prominent location and is to identify what an adult is, as defined in the standard in sub-clause 201.3.219.

• Added a requirement for the ifu to include a description of the intended Patient group(s). (Sub-clause 201.7.9.2.1e))
• Added a requirement that if the medical bed is limited to a specific group of patients to id that in the ifu. (Sub-clause 201.7.9.2.2e))
• Added a waning needs to be added to the ifu that incompatible side rails and mattresses can cause an entrapment hazard. (Sub-clause 201.7.9.2.2f))
• Updated figures 201.107 & 201.108 for medical beds with single or split/segmented side rails.
• Added a note related to sub-clause 201.9.8.3.2 on “static forces due to loading from persons” that support assemblies used in this test may be allowed to use a lower safety factor.
• Updated the Particular guidance and rationale section to incorporate “Adult” into this section of the standard for the Scope & Adult Definition.  (Annex AA, Section AA.2, Sub-clause 201.1.1 & definition 201.3.201)
• Added to Annex AA, Section AA.2 Guidance & Rationale for Sub-clause 201.4.2 a list of possible hazards of medical beds to consider.
• Delete a paragraph in Annex AA, Section AA.2, Sub-clause 201.9.101 – Protection against inadvertent falls.

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

If you need help with the IEC 60601 series of Standards, 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).

This blog discusses the following points:

• Definition of APPLIED PART
• Examples of APPLIED PARTS for specific medical devices
• Examples of different types of APPLIED PARTS (Type B, BF, CF or & each can be Defibrillator Proof for a total of 6 APPLIED PARTS classifications)
• 3 Notes in regard to the Definition of APPLIED PART

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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