Great News!!!! Effective 19 September 2023 FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program converted from a pilot program after 3 years to a permanent program, the agency announced. The transition is authorized under the Medical Device User Fee Amendments of 2022 (MDUFA V). The ASCA program’s goals are to:

• streamline the conformity assessment in medical device submissions,
• enhance the FDA’s confidence in test methods and results,
• decrease the need for additional information related to conformance with a standard,
• promote consistency, predictability, and efficiency in medical device review,
• serve as a least burdensome approach to conformity assessment

The ASCA program’s final guidance documents, issued in 2020, set the current framework for the program:

• Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program – Final Guidance (Program Guidance)
• Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the ASCA Pilot Program – Final Guidance (Standards Specific Guidance)
• Biocompatibility Testing of Medical Devices – Standards Specific Information for the ASCA Pilot Program – Final Guidance (Standards Specific Guidance)

The FDA grants ASCA accreditation to test labs that meet the requirements of the program. The ASCA test labs are authorized to conduct testing and the output from the lab is a summary report that the manufacturer submits to the FDA (more to come). Once the FDA approves an ASCA test lab the FDA identifies the scope of recognized consensus standards that the lab is able to test too (they are able to expand that list over time & the FDA may suspend any and all of the scope of the lab, if appropriate), the name & address of the lab and the ASCA contact on the ASCA test lab list. If the lab is suspended there seems to be a note in the current scope, there is no separate search feature on the db for active and suspended labs. I just sent in a request to the standards and conformity assessment (S-CAP) group that is in charge of this db to ask if they can make this more user friendly.

FDA has added standards to the list of approved standards beyond what is noted in both Standards Specific Final Guidance documents and plans to continue to add recognized consensus standards to the list/db. You can search the list of recognized consensus standards db but make sure you click the check box next to “Included in ASCA?” to view the list of standards that are included in the ASCA program. When you get to the link for a specific standard make sure you review the standard and see if any limitations on the standard if a partial or full recognition and also if there are any limits from the ASCA program perspective so you know what to expect. Then you need to make sure the test lab you are planning to use has the applicable standards in scope, that apply to the product that you want to test for your submission to the FDA.

You’ve chosen a test lab and gotten a test quote including the ASCA costs. Now you need to get the testing done but please make sure before you submit to the FDA you don’t have any comments on the summary report from the ASCA lab that aren’t positive towards the approval. If there are any issues you want to resolve them before a final report is issued from the test lab to the manufacturer. The manufacturer provides the summary report as part of the premarket submission, not the test lab. You want a clean summary report going to the FDA, as the FDA relies on the ASCA’s test lab summary report instead of the full test report that has been submitted in the past.

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines; need support when FDA, the ASCA program or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

On April 3, 2023 FDA added IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment – Part 1: General requirements for basic safety and essential performance to their list of Recognized Consensus Standards as Recognition # 19-49 in Recognition List # 060. A reminder that Recognized Consensus standards are considered voluntary by the FDA for premarket submissions but they are what the majority of manufacturers use to facilitate & streamline the premarket process.

Relevant FDA Guidance and/or Supportive Publications*

US national differences:

1. (Recognition Number: 19-46) ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]

2. Attachment Form No.: US_ND_IEC60601_1U ATTACHMENT TO TEST REPORT IEC 60601-1: US NATIONAL DIFFERENCES – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
(https://documents.iecee.org/ords/f?p=702:558:::::P558_DOCUMENT_FILE_ID:2955038)

Note from Leo: This is a US National Difference Test Report Form issued by the CB Scheme for CB scheme reports.

You have 3 options
1 expires after December 17, 2023
The first 2 are acceptable now & going forward.

1) Use IEC 60601-1 Edition 3.2 (Recognition # 19-49) from now onward making sure to use References #1 AND #2.
Note: This first option is the best of the three. Test to the IEC standard as that way you can prepare your product for the US domestic and international markets at the same time. If you pass the testing you’ll meet most if not all requirements and then you can deal with the few US National Differences by applying the US National Differences which are also in item 2) of this list anyway. This is less restrictive for your product than if you test your product to the US version of the standard (ANSI AAMI – Item 2 of this list) and then try to go to the international market which most countries will require IEC testing anyway.

2) Use ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (Recognition Number: 19-46) from now onward.
Note: This SIS is an older Recognized Consensus Standard but by inference, one would be wise to make sure that you also get the US National Difference Test Report mentioned above for the IEC 60601-1, ed. 3.2 which is based on the ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (Recognition Number: 19-46)

3) During the transition period FDA will accept a declaration of conformity in support of premarket submissions to the older ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) (Recognition Number: 19-4) but it will be superseded by recognition of ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) [Including Amendment 2 (2021)] (Recognition Number: 19-46) after December 17, 2023.
Note: The SIS says that Recognition Number: 19-4 (ANSI/AAMI ES60601-1, edition 3.1) by Recognition Number: 19-46 (ANSI/AAMI ES60601-1, edition 3.2) but if you are smart I would switch to Recognition Number 19-49 (IEC 60601-1, edition 3.2). FDA should accept this Recognized Consensus standard for your premarket submission as long as your submission includes the US national differences References #1 & #2.

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

So are you ready for all the changes of Amendment 2 of IEC 60601-1 and all the Amendments?

Join us for a live free webinar on an Insider’s look at IEC60601 Amendments: detailed guidance from a committee member responsible for changes – Aug 27, 10 AM PT/ 1 PM ET

With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that the full scope of changes to the IEC60601 series is massive, creating a swell of confusion around understanding the updates & how to transition for compliance.

Greenlight Guru has teamed up with Leonard Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants to share his expertise on the topic, notably his contributions to The Amendments Project.

This in-depth webinar will cover clarifying details around the massive changes of the Amendments Project, provide guidance on updated standards already published, insider knowledge into updated standards not yet published & what to expect, & how to prepare accordingly for the impact it will have on your firm and product lines.

SOME OF THE CHANGES WE WILL COVER INCLUDE: 

• Updates to IEC 60601-1 (Medical Electrical Equipment)
• Updates to IEC 60601-1-2 (EMC)
• Updates to IEC 60601-1-8 (Alarms)
• Impacts of standard changes on:
  • Design
  • Regulatory approvals (i.e. FDA vs EU Notified Body – current vs new standards)
  • Safety certifications
  • Labeling / markings / packaging
  • Tests/ retesting
  • Essential Performance
  • Risk Management File
  • Usability Engineering File
  • Software Life Cycle Process
• Q&A session

WHO SHOULD ATTEND?

• R&D Engineers and Management
• Regulatory Affairs Professionals and Management
• Quality Professionals and Management
• Medical Device Executives
• Clinical Affairs Professionals and Management

 Leo Eisner,

Topic:  Why Your Regulatory Strategy Can’t Ignore Medical Electrical Standards & Guidances

Track:  MD&M West: Regulatory & Quality Update

• The IEC 60601 series structure – why do all those dashes matter?
• An analysis of the medical electrical and related standards that have been recently updated or are in development, and how these standards interact with each other
• IEC 60601-1 and its collaterals (IEC 60601-1-XX standards) are going thru another set of changes – what are some of the impacts?
• What are the plans for aligning the particular standards (IEC 60601-2-XX & IEC/ISO 80601-2-XX) with the general (IEC 60601-1) and collateral standards in the 60601 series?
• Related standards that are in the process of change: ISO 14971, IEC 62366-1, and IEC 62304
• Standards and guidances inputs to your regulatory strategy (and product development plans) that need to be relayed to your regulatory, design and product development team members

Join in on the conversation thru LinkedIn

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.

Near the end of writing this article I had an unfortunate incident that I personally had to use a home use medical devices for 3 weeks of IV antibiotics (syringe pump – like an infusion pump but with a syringe instead of an IV bag) after a knee joint infection that I had to have emergent surgery & stay in the hospital for 2 days in Early June 2016.  I was out of work for about a month and so I got a close birds eye view of why the medical device and wellness device markets are exploding.  This explosion of interest comes from several factors including the “Super aging” of societies around the globe, Internet of Things (IoT), the portability of devices, the growth of wearable technologies and other factors discussed in the article.

There is a huge need to support those at home that are sick, injured, has an acute issue or chronic illness that want a comfortable life and would rather stay at home then be in a sterile hospital or other clinical setting any longer than they have too.  I know I was ready to get home after 2 days in the hospital, even though I had to rest at home, I was much more comfortable at home than in the hospital setting.  So, now I can appreciate how important it is to have these medical and wellness devices evaluated for the proper environment and proper standard(s) and to meet national regulations.   One of the issues that is important to this conversation is the blurry line between home use medical devices and wellness devices.  FDA has written guidances for both Home Use Medical Devices and Wellness Devices to clarify from their perspective.  There, also is a newer IEC System Committee called Active Assistive Living (SyC AAL) that is looking at the gaps in standards and other IEC technical documents for home use medical devices and non-medical devices (Some being wellness devices).  The article goes into detail on this SyC AAL and also looks at the medical electrical device standards focused around Home Use Medical Electrical Devices.

Enjoy the article and if you have interest in or need help with the IEC 60601-1 series, home use medical electrical devices or the SyC AAL please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants.

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).

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).