COMMISSION IMPLEMENTATION DECISION M/575 was issued 14 April 2021: This is a list of standards the EU Commission is hoping to Harmonize under MDR and IVDR.  One of the issues is the HAS consultant has issued a negative assessment on EN ISO 14971 which the CEN/CLC JTC3 leadership is working with the HAS consultant to address the issues and to draft acceptable European annexes so Harmonization can occur for the standard.  Many of the standards on the list in M/575 reference to EN ISO 14971 so it is highly likely that CEN and CENELEC will reject this newest version of the EU Commission Standardization Request again and we won’t have any Harmonized Standards by the Date of Application (26 May 2021) for the MDR which will cause lots of problems for manufacturers and Notified Bodies and cause more delays for the MDR & likely even for the IVDR I’m sorry to say.  Also, the MDCG 2021-5 “Guidance on standardisation for medical devices” doesn’t seem to clarify when harmonized standards are not published through the Offical Journal of the EU what to do.  In section 3.1 mentions Harmonized standards are voluntary with respect to the MDR & IVDR as they were for the MDD, AIMDD, & IVDD.  The closest the MDCG gets to it is to use the “State of Art” standards approach in section 3.5.

Another important observation is all the newest versions of the General & Collateral IEC 60601 Standards that were issued Summer of 2020 (EN versions were issued later in the year) are listed in Annex I of the EU Commission Standardization Request as the deadline to adopt these standards by 27 May 2024 — These are EN 60601-1, ed. 3.2; EN 60601-1-2, ed. 4.1; EN 60601-1-3, ed. 2.2; EN 60601-1-6, ed. 3.2; EN 60601-1-8, ed. 2.2; EN 60601-1-9, ed. 1.2; EN 60601-1-10, ed. 1.2; EN 60601-1-11, ed. 2.1; & EN 60601-1-12, ed. 1.1 – The Particular Standards EN 60601-2-XX or EN ISO 80601-2-XX listed are primarily based on the previous versions of the General & Collaterals of IEC 60601 standards on the M/575 list so this will likely cause conflicts vs the listed new standards mentioned here.

Follow the full discussion and updates to this post on LinkedIn

Confused this is what Eisner Safety Consultants experts deal with all the time for countries for these and many other standards, regulations, laws, directives, and more. Leo Eisner is an expert on standards development and sit on many standards committees. Let us help you through this process. 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 or through our contact form at https://eisnersafety.com/contact_eisner_safety/.

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).

What’s it about: The presentation guides you through many significant issues concerning the design & development of wearable medical devices. Leo will provides an in-depth look at the FDA guidance documents that may apply to your wearables, including the Home Use Environment, Mobile Medical Applications,  Accessories, and General Wellness  guidances among additional broader based ones.

Join us for this audio conference presentation and bring your group up  to speed as Leo guides you through the wide variety of FDA Guidances that may apply to your Wearable Medical Device. This audio conference will cover:

• Does the FDA consider your  wearable a medical device?
• FDA’s Final Guidances on Mobile Medical Applications & Home Use Environment
• The differences between the IEC & AAMI Home Use Environment Medical Electrical Equipment and Systems Standard (60601-1-11) and it’s impact on the FDA Home Use Guidance
• Draft General Wellness & Accessories Guidances
• Additional Regulations that may impact your Wearable device beyond the FDA

Click here for the details on the presentation & discount ($50.00 off regular price) and also some other past presentations from FX Conferences that we have presented.

Leo Eisner will be speaking on Medical Device Wearables and the Current Thinking from FDA with respect to myriad of new guidance documents that may apply to your devices.  This presentation is being offered 2 times in July (Tuesday July 21, 10:00AM Eastern and Thursday July 23, 1:00PM Eastern).  The best thing is you don’t have to travel to go to this presentation just dial in, download the material and you are set to learn from an industry expert.  As a special thank you for visiting us at Eisner Safety Consultants you can get a $50.00 (US$) discount.

Sign up now to take away some really valuable information in this fast moving industry.

What’s it about: This audio conference presentation guides attendees through many of the significant issues concerning the development of wearable medical devices. Leo provides an in-depth look at the guidance documents that may apply to your wearables, including the Mobile Medical Applications, Home Use Environment, General Wellness, and Accessories guidances among additional broader based ones.

Join us for this audio conference presentation and ease your regulatory stress as Leo guides you through the wide variety of FDA Guidances that may apply to your Wearable Medical Device. This audio conference will cover:

• Is your wearable a medical device per the FDA?
• FDA’s Final Mobile Medical Applications & Home Use Environment Guidances
• The differences between the IEC & AAMI versions of 60601-1-11 (Home Use Environment Medical Electrical Equipment and Systems) Standard and how it impacts your use of the Home Use Guidance
• Draft General Wellness & Accessories Guidances
• Other Regulations that can apply to Wearables outside of FDA
• Understanding which Recognized Consensus Standards may apply to your device

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

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).

Last summer Amendment 1 (A1) came out and if you haven’t yet you should start learning about those changes as they will be impacting you sooner rather than later (sign-up for an FX Conferences recording of my recent presentation on A1 of IEC 60601-1 and its’ impact on users, follow the instructions to get a $50.00 discount, and sign up for the presentation titled “IEC 60601–1, 3rd Edition, Amendment 1 and its Impact on Users”) and also A1 can help you as it will reduce the amount of Risk Management File work you need to do for a product safety certification or approval. There are about 25 less Risk Management File requirements when using A1 vs using 3^rd ed.  To understand the differences and changes of A1 it is highly recommended that you get the IEC 60601-1 edition 3.1 (consolidated) edition as that shows you where all the changes are to the text vs 3^rd ed.  Note, when you submit for testing thru a test lab you will either want to use either edition 3.1 or 3^rd ed. but you can’t mix and match as that would not work well and any CB scheme certified lab, among most other labs, will not mix and match requirements as it gets messy quickly.

So, what are the current changes to the standards related to alignment with 3^rd ed. & the new Interpretation Sheet?  Let’s start with the standards.

The updates are actually withdrawal of two standards that have been embedded into 3^rd ed. when it was released (i.e. IEC 60601-1-1, 2^nd edition – Medical Electrical Systems & IEC 60601-1-4 Programmable Electrical Medical Systems) and so the 2^nd ed. aligned standards needed to be withdrawn as 2^nd edition of IEC 60601-1 has been withdrawn since the publication of 3^rd edition back at the end of 2005.  The withdrawal report to IEC for IEC 60601-1-1, Edition 2.0 (now in IEC 60601-1, 3rd ed. in clause 16) covered the following 3 points, and it is the same circumstances for IEC 60601-1-4, edition 1.1 (1^st ed. + A1) (now in IEC 60601-1, 3rd ed. in clause 14):

• IEC 60601-1 Ed. 2.2 (IEC 60601-1:1988+A1:1991+A2:1995) was withdrawn in 2005, yet those who want to use it have been able to do so for the past seven years.
• IEC 60601-1 Ed. 2.2 makes normative reference to a number of supporting standards that have been revised or superseded, yet users have been able to find the versions they need to implement Edition 2.2.
• With the changes made in Amendment 1 to IEC 60601-1:2005, there are substantive technical differences between this collateral standard and its respective clause in IEC 60601-1 Ed. 3.1. Therefore, this document can no longer be considered to represent the generally accepted state of the art.

Let’s move onto the Interpretation Sheet 3 (or IS3) for IEC 60601-1 3^rd edition and also for edition 3.1 or 3^rd edition + A1.  It is the 3^rd interpretation sheet issued since IEC 60601-1, 3^rd edition has been issued.  IS3 is a clarification of the requirement for sub-clause 13.1.2, 4^th dashed line which the sub-clause is titled “Emissions, deformation of ENCLOSURE or exceeding maximum Temperature”.  The requirement of concern is:

“The following HAZARDOUS SITUATIONS shall not occur;”

“- ….”
“-     temperatures of ME EQUIPMENT parts that are not APPLIED PARTS but are likely to be touched, exceeding the allowable values in Table 23 when measured and adjusted as described in 11.1.3;”  (This is the fourth dashed line of 13.1.2)

So, this requirement is saying that this situation should not occur (following HAZARDOUS SITUATIONS) if there is a part that isn’t an APPLIED PART (An APPLIED PART is a part of the device that in NORMAL USE necessarily comes into physical contact with the PATIENT for the device to perform its function.  So, a part other than an APPLIED PART) that is likely to be touched that exceeds the temperature limits of Table 23 (Allowable max temperatures for ME EQUIPMENT parts that are likely to be touched) in the temperature test method described in sub-clause 11.3.

The IS3 gives an alternative route to meeting the above requirement by stating the following:

“This is clarified by the following:

The above requirement is regarded as fulfilled in accordance with Subclause 4.5 for temperatures at the surfaces of the enclosure, if the following conditions are fulfilled:

− The maximum allowed temperature on OPERATOR accessible surfaces in SINGLE FAULT CONDITION is 105 °C; and

− the instructions for use contain a warning that, under some SINGLE FAULT CONDITIONS, the temperature of: (indicate the surface of concern) could get hot and there is a possible RISK of a burn if touched, and

− if the RISK ANALYSIS demonstrates a need for a warning symbol on the ENCLOSURE, safety sign ISO 7010-W018 ( ) shall be used on or adjacent to the hot spot on the ENCLOSURE; and

− the RISK ASSESSMENT demonstrates that the temperature attained in the SINGLE FAULT CONDITION is acceptable, and

− the RISK ASSESSMENT demonstrates that applying the alternative RISK CONTROL measures in this Interpretation Sheet results in a RESIDUAL RISK that is comparable to the RESIDUAL RISK resulting from applying the requirement of the standard.

NOTE 1 This Interpretation Sheet is intended to be used with both Edition 3.0 and Edition 3.1 of IEC 60601-1.

NOTE 2 An example of an analysis that demonstrates an adequately low probability of occurrence of HARM is shown below.”

To access this IS3 for free please go to the IEC website link.

If you need assistance with this or other issues, please contact us at Leo@EisnerSafety.com.

What’s it about:  The FDA published its draft guidance on Design Considerations for Devices Intended for Home Use in December of 2012, as part of an initiative started back in April 2010 “to support the safe use of medical devices in the home.” The guidance document is a significant step forward helping manufacturers understand the design criteria, user environments to consider, environmental considerations, and labeling issues. It also looks at other standards and FDA guidance manufacturers should consider, as well as post-market considerations, and other vital aspects of designing and developing devices that are intended to make the devices safer and easier to use.

Join us for this timely and informative audio conference presentation as our speaker takes attendees on a guided tour of the draft guidance. The presentation reviews the key points of the document as it relates to the IEC 60601-1-11 standard (Home Use Medical Electrical Equipment), human factors and usability (user environment), environmental considerations, labeling, and design controls (including risk management).

This audio conference will cover:

• Variations in the definition of home-use device under FDA and IEC 60601-1-11
• How the draft guidance relates to FDA’s Medical Device Home Use Initiative
• Environmental considerations discussed in the draft guidance
• User environments to be considered
• Key elements to keep in mind when designing home-use devices
• Labeling considerations
• Post-market considerations
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

Topic: “Make sense of the IEC 60601-1-11 standard” The Medical Electrical Device Collateral Standard in the Home Healthcare Environment

Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Joseph Murnane of Underwriters Laboratories

When: Feb 10, 2011 (Thursday)

Where: Anaheim Convention Center while you are at the MD&M West Conference

What’s it about: The market for home healthcare equipment is expected to grow exponentially over the coming years, as the delivery of healthcare services shifts from clinical settings to the home. But manufacturers face a series of unique challenges in supplying home healthcare equipment that is both effective and safe. IEC 60601-1-11 “Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in Home Care Applications” was recently published to address the safety hazards that exist when medical devices are moved into the home. IEC 60601-1-11 is a collateral standard, meaning that it directly references provisions in IEC 60601-1, and is used in conjunction with IEC 60601-1 for the certification of home healthcare equipment. In addition to the publication of the new standard, FDA has launched the Medical Device Home Use Initiative, which is expected to impact the regulatory approvals of medical devices for use in the home. In this presentation, two leading experts in medical device safety, one who participated in the writing of IEC 60601-1-11 and the other working on a sister standard for the emergency medical services type electrical medical devices, will discuss the major considerations all design engineers must consider when designing a medical device that may be marketed for home use.

Learn more: About DesignMed West 2011

Conference Registration: Webpage

Please feel free to contact us on this matter if you would like some assistance in learning more about this proposed standard as it applies to your products.

Leo@EisnerSafety.com 
503-244-6151 (USA)