Leo Eisner, the “IEC 60601 Guy” & Principal Consultant, of Eisner Safety Consultants attended several IEC SC 62A Maintenance Team (MT 28 & MT 30) and Working Group (WG14) meetings from March 22 – March 31, 2017 in Oslo, Norway and London, United Kingdom to start the work of reviewing the items agreed on (in Frankfurt Oct 2016) for IEC 60601-1, 3rd ed. + Amendment 2 (or ed. 3.2) for development and comment.

A2 of IEC 60601-1 & its’ related collateral standards are anticipated to be published by the end of 2019.  In only 2+ short years from now!!!!  Will you be ready?  We are offering a web special til the end of March May 2017 on our Annual Standards Trends Reports.  See more below.

A2 changes & collaterals changes may include any of the following:

• safety gaps needing corrections,
• known problems for regulatory bodies,
•  inconsistencies within the standard,
• technical errors, and
• updates of standard references.

The above was the criteria for the ‘Short List’ vote on which items were agreed to in Frankfurt (Oct ’16) for A2 for IEC 60601-1 and it’s collateral standards.

Also, you need to be aware that the items that didn’t make it to the ‘short list’ are slated to be worked on for the 4th edition of IEC 60601-1 (the ‘long list’) which is scheduled to be published in 2024.  This will be a much more significant set of changes including potentially restructuring the standard and maybe even making the whole series a database standard.

Are you ready for changes coming for 60601-1, 3rd edition + Amendment 2 and 4th edition of IEC 60601-1?

We can help you stay up to date and ahead of the curve so you are prepared for these changes that are coming.  Check out our Annual Standards Trends Report as a fantastic resource that can save your company significant time and money (upwards of $100,000+).

To provide you an opportunity to receive the Eisner Safety Consultants Annual Standards Trends Reports for a significant discount of this year’s copy of these reports (publication between Late May to June 2017) we are offering a web special til the end of March May 2017 to give you the opportunity to learn from Leo about the Amendment 2 meetings in Oslo, Norway and London, U.K. The reports will include more details where these Amendment 2 changes are at and what these changes are.  If you want to stay ahead of your competitors, and save on the cost of standards committee membership fees, save on travel expenses, save time instead of sitting in these meetings, and getting the benefit of staying up to date on medical electrical equipment & systems (MEE&S) standards and home use MEE&S standard consider this amazing deal:

Eisner Safety Consultants

Annual Standards Trends Reports on MEE&S &

Home Use MEE&S Options

Get This Year’s Report(s): May/June 2017 Annual Standards Trends Report (ASTR) Options:

Normally priced at $1,997.00 Web Special $1,597.00 for the:

May/June 2017 Medical Electrical Equipment & Systems (MEE&S) ASTR OR

May/June 2017 Home Use MEE&S ASTR

Normally priced at $2,997.00 Web Special $2,497.00 for the:

Bundle pricing of both the May/June 2017 MEES & Home Use MEE&S ASTRs

Get This & Last Year’s Report(s): March 2016* & May/June 2017 ASTRs Options:

Normally priced at $2,397.00 Web Special $1,997.00 for the:

March 2016* & May/June 2017 Medical Electrical Equipment & Systems (MEE&S) ASTRs OR

March 2016* & May/June 2017 Home Use MEE&S ASTRs

Normally priced at $3,697.00 Web Special $2,997.00 for the:

Bundle pricing for all 4 Reports – March 2016* & May/June 2017 of both MEE&S & Home Use MEE&S ASTRs

* = MAR ‘16 ASTRs issued as of MAR ‘16 with no updates for these ridiculously low rates.

If you need help with IEC 60601-1 please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants and considered the ‘IEC 60601 Guy’ by many of his clients and associates.

A reminder that FDA Guidances and Recognized Consensus Standards are voluntary.  But I remind my clients’ that if you don’t use these voluntary documents for premarket submissions you make your life and the reviewer’s life a lot harder, typically.  So, I recommend, in most cases, to use these voluntary documents to speed up the process, in the long run.  In the short run, you may need to do more testing but if you don’t you risk the chance of your product not being accepted by the FDA.

The Guidance goes on to say that “the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device under review, as well as the use of appropriate FDA-recognized standards or appropriate consensus standards.”  The Guidance indicates that manufacturers typically reference in premarket submissions Recognized consesnsus national (US) and international standards such as IEC 60601-1-2²) (3rd or 4th edition) Medical Electrical Equipment EMC standard, device specific Particular Standards such as IEC 60601-2-XX, and lastly they reference other consensus standards for electrically-powered deevices that include information on EMC such as ISO 14708³ for active implantable medical devices.

The Guidance continues with a listing of details that FDA is expecting manufacturer’s provide in their premarket submissions, so the medical device EMC information is clear and consistent information for the submission, and are consistent with the specifications included in the standards, as referenced above, that are applied to the premarket submission.  The Guidance points to the FDA Recognized Consensus Standards database located at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

The rest of the Guidance, Section II “EMC Information”, details the list of items the FDA is expecting of the manufacturer’s for premarket submissions.  And of course the FDA leaves an opening for a broad statement at the end of the section that says: “Additional information not outlined above may be requested by FDA depending on intended use and intended use environment for specific active medical devices (e.g. implantable portions of active devices) to demonstrate the device’s claims regarding electromagnetic compatibility (EMC).”

If you need help with this FDA Draft Guidance or with IEC 60601-1-2 edition 3 or edition 4 or you are interested in our new Eisner Safety Consultants Standards Reconnaissance Database please email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

^{Footnotes cited from FDA Draft Guidance Document issued on 2 Nov 2015 titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”}

<sup>1. According to International definitions, “disturbance” is the cause and “interference” is the effect. In the US, “interference” is often used interchangeably for both cause and effect though more often for the cause. 
2. IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, IEC 60601-1-2:2014 [4th Ed.], Medical Electrical Equipment, Part 1 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests, AAMI/ANSI/IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, and AAMI/ANSI/IEC 60601-1-2: 2014 [4th Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests 
3. ISO 14708-3 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators</sup>

This post discusses Health Canada’s most current List of Recognized Standards for Medical Devices effective 31 Aug 2015.

Health Canada updated their list of Recognized Standards for Medical Devices on August 31, 2015.  The changes included additions, updates and removals to the listing.  Part of the update was adding the Canadian National Version of IEC 60601-1, edition 3.1 (or 3rd edition + Amendment 1) which is the Canadian National Standard CAN/CSA C22.2 No. 60601-1:14 (issued in 2014).  It includes some Canadian National Deviations in the standard.  To find out more detail about this standard please refer to a blog post  I wrote back in 2014 on the topic.  The IEC 60601-1:2012-Ed.3.1 was also added to this Listing.

Several other changes of significance to the list of Recognized Standards for Medical Devices include.  This is a partial list of changes so refer to the list for more details:

1. The addition of the previous version of IEC 60601-1-11:2010-Ed. 1.0 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. For those that subscribe to the Eisner Safety Consultants Standards Reconnaissance Database you would know that the current version of IEC 60601-1-11 was updated in 2015.  This version of the standard is not on the Health Canada List of Recognized Standards for Medical Devices as of yet.
2. The removal of ISO 9919:2005 Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.  This standard has a replacement which was placed on the list previously which is ISO 80601-2-61:2011-Ed.1.0, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.  In the Foreword of the ISO 80601-2-61:2011 it says “This first edition of ISO 80601-2-61 cancels and replaces the second edition of ISO 9919:2005, which has been revised to harmonize it with the third edition of IEC 60601-1:2005.” So, the ISO 9919 standard has now been replaced by ISO 80601-2-61.  To find out more details about this standard in regard to the FDA & Health Canada Recognized Standards Lists you may want consider subscribing to the Eisner Safety Consultants Standards Reconnaissance Database.  We provide you with the FDA & Health Canada information about each standard that is in the database.  This way you don’t have to search an extra databases as this information is all in one place for each standard.  
3. The list added another older standard IEC 62366:2007 Medical devices – Application of usability engineering to medical devices.  The more recent version is IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering to medical devices.  The Foreword of the most recent standard indicates “This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014).”  The summary of changes noted here is part of the information we provide in each of the current versions of the standards for our paid subscribers for the Eisner Safety Consultants Standards Reconnaissance Database
4. The Canadian and the International versions of IEC 60601-1, 2nd edition have been removed from the list including: CSA C22.2 NO. 601.1 M90 (R2006) Medical electrical equipment – Part 1: General requirements for safety (adopted amendment 2:1995 to IEC 601-1:1990) and IEC 60601-1:1988-Ed.2.0 Medical electrical equipment – Part 1: General requirements for basic safety + IEC 60601-1/Amd.1:1991 + IEC 60601-1/Amd.2:1995 + IEC 60601-1/Cor.1:1995.

These are just some of the changes that are of importance.  The below listings shows the August 31, 2015 Additions, Updates, and Removals to the Health Canada List of Recognized Standards for Medical Devices.  When there are updates to Regulatory Lists of Standards we will update the Eisner Safety Consultants Standards Reconnaissance Database listing as soon as possible so you are kept up to date on the changes to the standards of that specific Regulator. Currently we are monintoring the list of standards for FDA & Health Canada.  In the near future we will be adding in the European List of Harmonized Standards to this monitoring process.

Below are the 3 parts of the Health Canada list that have changed:

The Additions to the list of Recognized Standards include the following:

• ISO 5840-3:2013 Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
• ISO 14117:2012-Ed.1.0 Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
• IEC 60601-1:2012-Ed.3.1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
• CAN/CSA-C22.2 NO. 60601-1:14 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-11:2010-Ed. 1.0 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
• IEC 60601-2-57:2011-Ed.1.0 Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
• IEC 62366:2007 Medical devices – Application of usability engineering to medical devices
• ISO 13408-1:2008 Aseptic processing of health care products – Part 1: General requirements
• ISO 13408-2:2003 Aseptic processing of health care products – Part 2: Filtration
• ISO 13408-3:2006 Aseptic processing of health care products – Part 3: Lyophilization
• ISO 13408-4:2005 Aseptic processing of health care products – Part 4: Clean-in-place technologies
• ISO 13408-5:2006 Aseptic processing of health care products – Part 5: Sterilization in place
• ISO 13408-6:2005 Aseptic processing of health care products – Part 6: Isolator systems
• ISO 13408-7:2012 Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products
• ISO 14644-1:1999 Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness
• ISO 14644-2:2000 Cleanrooms and associated controlled environments – Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
• ISO 14644-3:2005 Cleanrooms and associated controlled environments – Part 3: Test methods
• ISO 14644-4:2001 Cleanrooms and associated controlled environments – Part 4: Design, construction and start-up
• ISO 14644-5:2004 Cleanrooms and associated controlled environments – Part 5: Operations
• ISO 14644-6:2007 Cleanrooms and associated controlled environments – Part 6: Vocabulary
• ISO 14644-7:2004 Cleanrooms and associated controlled environments – Part 7: Separative devices (clean air hoods, glove boxes, isolators and mini-environments)
• ISO 14644-8:2012 Cleanrooms and associated controlled environments – Part 8: Classification of air cleanliness by chemical concentration (ACC)
• ISO 14644-9:2012 Cleanrooms and associated controlled environments – Part 9: Classification of surface cleanliness by particle concentration
• ISO 14644-10:2013 Cleanrooms and associated controlled environments – Part 10: Classification of surface cleanliness by chemical concentration
• ISO 14698-1:2003 Cleanrooms and associated controlled environments – Biocontamination control – Part 1: General principles and methods
• ISO 14698-2:2003 Cleanrooms and associated controlled environments – Biocontamination control – Part 2: Evaluation and interpretation of biocontamination data
• ASTM F2028-14 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

The Updates to the list of Recognized Standards include the following:

• ISO 14708-2:2012 Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers
• IEC 60601-2-24:2012-Ed.2.0 Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
  Note: Additional accuracy testing results for flow rates below 1 mL/h may be required depending on the pump’s intended use
• IEC 60825-1:2014-Ed.3.0 Safety of laser products – Part 1: Equipment classification and requirements
• CSA Z900.1-12 Cells tissues, and organs for transplantation: General requirements
• ASTM F1160-14 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
• ASTM F1377-13 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
• ASTM F1717-14 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• ASTM F1798-13 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
• ASTM F2943-14 Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants

The Removals to the list of Recognized Standards include the following:

• ISO 9919:2005 Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
• ISO 21647:2004 Medical electrical equipment – Particular requirements for the basic safety and essential performance of respiratory gas monitors
  ISO 21647/Cor.1:2005
• ANSI/AAMI DF80:2003 Medical electrical equipment – Part 2-4: Particular requirements for the safety of cardiac defibrillators (including automated external defibrillators)
• ANSI/AAMI PC69:2000 Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
• ANSI/AAMI PC69:2007 Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
  ANSI/AAMI PC69/ERTA:2008
• CSA C22.2 NO. 601.1 M90 (R2006)
  Medical electrical equipment – Part 1: General requirements for safety (adopted amendment 2:1995 to IEC 601-1:1990)
• CSA C22.2 NO. 60601-1-2A-03 (R2006)
  Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests (Adopted Amendment 1:2004 to IEC 60601-1-2:2001)
• IEC 60601-1:1988-Ed.2.0
  Medical electrical equipment – Part 1: General requirements for basic safety
  IEC 60601-1/Amd.1:1991
  IEC 60601-1/Amd.2:1995
  IEC 60601-1/Cor.1:1995
• IEC 60601-1-2:2004-Ed.2.1
  Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard – Electromagnetic compatibility – Requirements and tests
• IEC 60601-1-4:2000-Ed.1.1
  Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems
• IEC 60601-1-6:2006-Ed.2.0
  Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability
• IEC 60601-2-10:1987-Ed.1.0
  Medical electrical equipment – Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
  IEC 60601-2-10/Cor.1:1987
  IEC 60601-2-10/Amd.1:2001
• IEC 60601-2-25:1993-Ed.1.0
  Medical electrical equipment – Part 2-25: Particular requirements for the safety of electrocardiographs
  IEC 60601-2-25/Amd.1:1999
• IEC 60601-2-26:2002-Ed.2.0
  Medical electrical equipment – Part 2-26: Particular requirements for the safety of electroencephalographs
• IEC 60601-2-36:1997-Ed.1.0
  Medical electrical equipment – Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
• IEC 60601-2-47:2001-Ed.1.0
  Medical electrical equipment – Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
• IEC 60601-2-51:2003-Ed.1.0
  Medical electrical equipment – Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

If you need help withCAN/CSA C22.2 No. 60601-1:14 or IEC 60601-1, 3rd edition or edition 3.1 or you are interested in the Eisner Safety Consultants Standards Reconnaissance Database please email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

Topic: “Wearable Devices: How to Make Them Safe and Adhere to Regulations”

Presenters: Leo Eisner & Mary Weick-Brady of Eisner Safety Consultants and Bakul Patel of OC, CDRH, FDA

Session Leader: Seth Goldenberg, PhD, director, Global Regulatory Strategy, NAMSA

When: October 26, 2015 (Monday), 3:30PM – 5:00PM Eastern

Where: RAPS Regualtory Convergence Conference (Register to Join the Conference)

As the use of medical device wearables continues to grow, how does the medical device industry stay abreast of the proper regulations and standards that apply to these devices when seeking clearance? Industry and agency experts will discuss applicable regulations and standards and what is required for regulatory submissions for medical device wearables. Learn to better identify the applicable standards and regulations to consider for medical device wearables during regulatory submission.

If you need additional support for Wearable Medical Devices and Home Use Medical Devices email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

11 June 2015 – Scrip Regulatory Affairs – Article written by Leo Eisner titled “Everything you needed to know about who’s doing what where with IEC 60601-1 – Part 1” Article discusses how the standard (IEC 60601-1 3rd ed. or ed. 3.1) is being used by Regulatory & Standards Organizations for the USA and Canada.

To read this article please go to Featured Articles webpage. Thank you Scrip Regulatory Affairs for allowing us to post on our Featured Articles Page of our Website.  This is not for public distribution please refer your associates that you want to read the article directly to the Featured Articles webpage.

We are in the process of setting up a standards reconnaissance service where we monitor the MEDICAL ELECTRICAL EQUIPMENT and HOME USE MEDICAL ELECTRICAL standards of your choice.  If you are interested in this service please contact Leo Eisner at Leo@EisnerSafety.com or 503-244-6151.  We would be happy to discuss what we can do for your organization as Leo is on many of the standards committees that these standards are involved with.  Below is a summary of my involvement in these committees.

Leo is a co-chair of the U.S. TAG (technical advisory group) for IEC/SC 62D, a member of the US TAG for TC 62 (Electrical Equipment in Medical Practice), SC 62A (Common Aspects of Electrical Equipment Used in Medical Practice) and SC 62D (Electromedical equipment).  He is the convener of SC62D JWG9 “Lens removal and vitrectomy devices for ophthalmic surgery”.  Leo is a member of the TC 62/SC 62A/WG 14 (Testing to General Safety Standard – The Working Group is chartered to develop recommendations regarding interpretation & application of IEC 60601-1 to testing of medical electrical equipment, and to deal with general testing requirements not assigned to other maintenance teams.)  To support the increase in demand for medical device Home Use and Wearables Leo is a member of the AAMI committee for Home Use Medical Devices and the US TAG for Active Assisted Living Syc (System Committee for all devices in various categories for the elderly which includes the home use medical device industry).

IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3^rd ed. Published

This post discusses the recently published Guidance IEC TR 60601-4-3:2015 that issues interpretations of IEC 60601-1, 3rd ed. and edition 3.1.

The technical report tiled IEC TR 60601-4-3:2015 Guidance & interpretation – Considerations of unaddressed safety aspects in the 3^rd ed of IEC 60601-1 & proposal for new requirements was released April 2015.  It deals with recommendations and interpretations of the IEC 60601-1, 3^rd ed. and edition 3.1 (or 3^rd ed. + A1).  IEC Subcommittee (SC) 62A established a process under which Working Group (WG) 14 would develop recommendations regarding problems of interpretation or application of IEC 60601-1.  I am a member of this WG.  Many of the WG14 experts are employed by test laboratories and manufacturers and have many years experience applying IEC 60601-1 to MEDICAL ELECTRICAL EQUIPMENT.  The one thing to be crystal clear about is in the INTRODUCTION of the document it says:

“While the National Committee members of SC 62A nominate these experts, their recommendations were not to be formally adopted through any official voting procedure. To reinforce this process, the Subcommittee specifically directed that the following note appear on every page of the resulting informational circular:

IMPORTANT NOTE: Per the 62A decision at Sydney…, the 62A Secretary is circulating this recommendation,…regarding problems of interpretation or application of IEC 60601-1 to all P-Member NCs.

This recommendation/interpretation is the result of considerations by a group of nominated experts and has not been formally adopted through any National Committee voting procedure. Distribution is only for information.

The INTRODUCTION of this Technical Report goes on to say:

“This technical report is intended to convey the results of WG 14’s work to interested parties such as MANUFACTURERS and test laboratories while retaining the informative nature of the material.

This first edition of IEC TR 60601-4-3 contains 93 recommendations, numbered 101 to 193. All these recommendations are based upon IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

The numbering starts with 101 instead of just 1 to ensure that these WG 14 recommendations (101 to 193) will not accidentally be confused with previous issued WG 14 recommendations 1 to 63, which are based on the second edition of IEC 60601-1 and published in IEC TR 62296.”

The other purpose of this document is that these recommendations may be potential sources for some of the changes to the IEC 60601-1 standard when it is up for it’s next round of changes.  The standards committees, working groups, and maintenance committees for IEC 60601-1 and it’s collateral standards (IEC 60601-1-XX) are in discussion if the next revision will start late this year or early next year.  There is a meeting of all the TC 62 (& SC62A – D) committees in Kobe Japan in Nov 2015 that will discuss this and probably have a formal vote to decide on the fate of the next revision of IEC 60601-1.  I plan to be at these meetings and involved in the discussions and decisions. If this vote is positive the earliest the changes would occur is sometime in 2019.  Stay tuned for more updates on the potential changes to the IEC 60601-1 standards and it’s related collateral standards.

As there are 93 recommendations sheets I will not note all of them in the below list but a sampling showing a cross section of the ones that draw my attention.  You can see from the list below that many of these were not addressed fully in the standard and this is the start of the resolution to these issues. Many of test houses use this document as their interpretations that they rely on until these decisions are finalized by being adopted into the next revision of the applicable standard (primarily IEC 60601-1).  But realize as the boxed text says these are not formalized so your test lab may not rely on them.  I would suggest that you check first with your Test Lab on the specific issues before assuming they are their interpretations.  You don’t want to use these and find out at the end of your test project that your lab doesn’t agree to the perspective on one or more of these recommendation sheets.  I would hate to see you redesign a product to find out the solution doesn’t meet the requirements for your lab.  As mentioned many labs do accept these but with added text box please be diligent and check first:

3.2.101             Total PATIENT LEAKAGE CURRENT of a ME SYSTEM

3.2.102             Pollution degree for MOPP

3.2.103             Transients on d.c. mains

3.2.104             Altitude factor for DEFIBRILLATION-PROOF APPLIED PARTS

3.2.105             Defibrillation energy protection for MOOP / MOPP

3.2.106             Overvoltage categories III and IV

3.2.107             Pollution degree related to different micro/macro environments

3.2.108             Warnings versus ALARM SIGNALS

3.2.109             Single Y1 capacitor for MOPP

3.2.111             CREEPAGE DISTANCE and AIR CLEARANCE for dental equipment

3.2.112             Short circuiting of one constituent part of DOUBLE INSULATION

3.2.113             Instability in transport position

3.2.116             Instability excluding transport position

3.2.119             Test equipment for recurrent tests according to IEC 62353 testing used within IEC 60601-1 type approval testing

3.2.124             WORKING VOLTAGE measurement

3.2.125             Defibrillation test

3.2.127             PERMANENTLY INSTALLED ME EQUIPMENT in the HOME HEALTHCARE ENVIRONMENT

3.2.129             Push buttons

3.2.132             Eye-verification of tester before legibility test

3.2.125             Labeling: spare parts vs. detachable parts vs. ACCESSORIES

3.2.144             Impedance of a PROTECTIVE EARTH CONDUCTOR within a DETACHABLE POWER SUPPLY CORD

3.2.149             Expected voltage on SIP/SOPs

3.2.151             COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS

3.2.153             Critical components

3.2.166             Keep dry and umbrella symbol

3.2.167             MOBILE and STATIONARY ME EQUIPMENT with wheels

3.2.175             Biocompatibility for quasi APPLIED PARTS

3.2.182             Chargers for ME EQUIPMENT used at home

3.2.186             Rationale for IP2X

3.2.187             Battery – limited power

3.2.191             The SIP/SOP pin to earth TOUCH CURRENT

3.2.193             MAINS VOLTAGE on APPLIED PART

This is a great resource to have throughout your design process and through the testing and beyond.  Always have it available so you can leverage the knowledge of these WG14 experts, including myself.  You can purchase this document from IEC, AAMI, and many other sources.  Go to http://www.eisnersafety.com/links/ to find a listing of standards Sales Organizations and also Standards Organizations.

We are in the process of setting up a standards reconnaissance service where we monitor the MEDICAL ELECTRICAL EQUIPMENT and HOME USE MEDICAL ELECTRICAL standards of your choice.  If you are interested in this service please contact Leo Eisner at Leo@EisnerSafety.com or 503-244-6151.  We would be happy to discuss what we can do for your organization as Leo is on many of the standards committees that these standards are involved with.  Below is a summary of my involvement in these committees.

Leo is a co-chair of the U.S. TAG (technical advisory group) for IEC/SC 62D, a member of the US TAG for TC 62 (Electrical Equipment in Medical Practice), SC 62A (Common Aspects of Electrical Equipment Used in Medical Practice) and SC 62D (Electromedical equipment).  He is the convener of SC62D JWG9 “Lens removal and vitrectomy devices for ophthalmic surgery”.  Leo is a member of the TC 62/SC 62A/WG 14 (Testing to General Safety Standard – The Working Group is chartered to develop recommendations regarding interpretation & application of IEC 60601-1 to testing of medical electrical equipment, and to deal with general testing requirements not assigned to other maintenance teams.)  To support the increase in demand for medical device Home Use and Wearables Leo is a member of the AAMI committee for Home Use Medical Devices and the US TAG for Active Assisted Living Syc (System Committee for all devices in various categories for the elderly which includes the home use medical device industry).

Our Associate Dale Hallerberg provided a short note about this recently published AAMI Guideline on Medical Device Safety Testing.

AAMI has published Technical Information Report (TIR) 62354:2015 “General testing procedures for medical electrical equipment”.  This report is available from AAMI at http://my.aami.org/store/SearchResults.aspx?searchterm=62354&searchoption=ALL. This document is identical to the IEC TR 62354:2014 published last September, and gives detailed guidance to manufacturers, test houses, and other interested parties on the steps involved in the safety testing of medical electrical equipment.  It builds on the test requirements of IEC 60601-1:1988 (including the collateral provisions of IEC 60601-1-1:2000) and IEC 60601-1:2005 and IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 but goes much further into testing details.  Examples of the content of the TIR include a description of the power supply needed for testing, the sequence of testing, the test equipment needed for each test, production-line tests, and much more.

This Report is not normative — which means it is not mandatory — however it gives excellent guidance and should be read and used by any laboratory interested in accurate, repeatable testing of medical electrical equipment or manufacturer and other interested parties in learning more about how the tests are conducted when their product goes to a test lab for IEC 60601-1 Certification Testing.  

If you need additional support for any of the IEC 60601 series of standards please 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 post discusses NRTL’s approved for AAMI ES 60601-1 3^rd ed. + A1 & can issue NRTL Marks vs which are in process.

There has been a lot of activity from OSHA with respect to the NRTL (Nationally Recognized Test Laboratory) program of late for medical device testing.  UL 60601-1 is still an approved standard that an approved NRTL can issue a NRTL test mark too but a few of the NRTL’s have now been recently approved to issue a NRTL Mark to AAMI ES 60601-1 3^rd edition + Amendment 1.  Once UL formally announces that UL 60601-1 will be withdrawn will OSHA take steps to withdraw that standard from their list of Approved Standard so that could a long time from now as I have not heard any word that UL wants to withdraw the UL 60601-1 (equivalent to 2nd ed. of IEC 60601-1 + US National Deviations).  Note, from several of my past blog posts OSHA has only allowed approved NRTL’s to use the standard AAMI ES 60601-1 3^rd edition with Amendment 1 or with additional amendments to ‘future-proof’ the standard (Can an OSHA NRTL Certify to ANSI/AAMI ES60601-1:2005/(R)2012 with Amendments Yet? & Q&A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1 & OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards).  OSHA did not like the standard AAMI ES 60601-1 3^rd edition by itself without the amendment and that is why it took so long before OSHA allowed a US based version of 3^rd ed. of IEC 60601-1.

The best place to confirm if a Safety Test Lab is an approved NRTL for the medical device standard AAMI ES 60601-1 3^rd edition + Amendment 1 is by confirming the notifications published in the US Federal Register.  The second best place is the OSHA NRTL website for the specifically approved NRTL.  The reason why the NRTL website is my second source is it seems like it takes some time (i.e. several weeks to a month or so) for OSHA to update the site to get the most recently approved standards listed for the specific NRTL for the specific NRTL webpage. 

So, which labs are currently approved to issue a NRTL Mark for the standard AAMI ES 60601-1 3^rd edition + Amendment 1?

There are a couple other NRTL’s that are in process of being approved for this standard too but are not at the Final Decision Federal Register Announcement stage quite yet.  They include:

So, once the 2nd list of NRTL’s are Recognized for the AAMI ES 60601-1, for 3^rd + Amendment 1 these NRTL’s will finally be authorized to allow their clients, after passing the applicable testing for their product(s), to place a US NRTL Test Mark on their client product(s). The first list in this blog post those NRTL’s are currently authorized to allow their clients, after passing the applicable testing for their product(s), to place a US NRTL Test Mark on their client product(s) to the ANSI/AAMI ES60601-1:2005/2012.

One additional piece of OSHA NRTL news is that I, Leo Eisner of Eisner Safety Consultants proposed to OSHA, on June 30, 2014, adding all current US based standards related to the US national standards of IEC 60601 series (AAMI standards).  If you would like to read the letter with this list that was sent in to OSHA Read it here.   Based on the letter I sent into OSHA a Federal Register Notice was issued on Nov 6, 2014 that proposed adding in all the standards I proposed (& a couple other non-related standards), with a close of comments date of December 8, 2014.  The list of proposed standards is noted below from part of the Federal Register Notice:

There were 2 comments on this specific notice.  1 comment was not related to the standards that I proposed and the other was specific to the list of standards I referred to.  Curtis-Straus believes that the detailed list should not be added to the NRTL list of Approved Standards because the general standard ANSI/AAMI ES 60601-1:2005/2012(R) refers to the Particular and Collateral Standards of the 60601-1 series (letter attached) but they miss the point that not all of these standards have been developed and maintained by a US based SDO (Standards Development Organization such as ANSI, AAMI, UL, etc.) which is an OSHA requirement. But I requested these standards specifically because my OSHA contact indicated that no IEC 60601 series standards that aren’t specifically US based standards (i.e. developed by a US based SDO) can be used to issue a US NRTL Test Mark.  So, if these US based medical device standard(s) are approved by OSHA the approved NRTL’s for those standards would be able to issue a US NRTL Mark for those standards once OSHA approves the Test Labs for this list of standards.  I do not know based on Curtis-Straus’s comments what OSHA will do with this list now.  I will check into the issue and report back on this topic.  

If you need additional support for ANSI/AAMI ES60601-1: 2005/(R)2012 or IEC 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).

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 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