𝗪𝗵𝗮𝘁 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗔𝗽𝗽𝗹𝘆 𝘁𝗼 𝗠𝘆 𝗗𝗲𝘃𝗶𝗰𝗲? Podcast with one of the best MedTech podcasters Etienne Nichols – Greenlight Guru‘s very own

𝗞𝗲𝘆 𝗧𝗼𝗽𝗶𝗰𝘀:
• Why standards like IEC60601 are crucial for medical device development
• Steps for identifying proper standards for your product
• How to integrate standards into your design process
• Mistakes & consequences of ignoring standards
• Tools for staying updated on changing standards & regulations
• How startups can navigate standards with limited resources

If you have any thoughts and comments on the podcast I’d would like to hear from you Comment on the LinkedIn post about the Podcast

If you found this interesting or helpful, consider Reposting on LinkedIn; follow me, Leonard (Leo) Eisner, the60601Guy and click the so you don’t miss future content.

Need help with 60601 series standards including EMC; strategic compliance 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. Eisner Safety Consultants team of experts also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more. His team includes experts on additional standards committees and we all talk to the regulators regularly. We’re here to support your needs.

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

Feel free to schedule a web meeting with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

We are thrilled to announce three incredibly talented individuals joining the Eisner Safety Consultants Team to support your needs.

Beat Keller’s expertise comprises the IEC 60601 series, software, and regulatory/quality. In the regulatory/quality area, he focuses on EU MDR, Swiss MedDO, and UK MDR.

Lisa Donlon’s expertise encompasses device regulatory/submissions and quality. Her focus is on EU MDR, clinical Evaluation Assessment, and NB Remediation.

Dan Modi’s expertise spans the IEC 60601 Series, EMC, design quality, device submissions/regulatory – EU MDR, U.S., India, China, Brazil, Japan, and more.

We have strengthened our team to support your needs so please feel free to schedule a meeting to discuss your needs or contact us.

Webinar: Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers

When: Tuesday, June 25, 2024  

Time: 11:00 a.m. – 12:00 p.m. EDT 

About the Event: Join BSI & Leo Eisner for an insightful webinar that explores how North American medical device manufacturers can harness the power of the CB Scheme to enhance their global market access. Leo the “IEC 60601-1 Guy” will present the significant updates introduced in the latest edition of IEC 60601-1 Ed. 3.2, which will impact medical device manufacturers.

Sign up for this webinar

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; 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.

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.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.

Q4’ 2027: Article 123 (3) (d) MDR/113 (3) (f) IVDR

• Actor (Economic Operators register in EUDAMED; Supervising Entities has access to EUDAMED that is not public),
• Certificates (Active, suspended, reinstated, withdrawn, refused, other restrictions on certificates),
• MSU (Evaluation of devices on the market by Competent Authorities),
• Vigilance (& Post Market Surveillance), and
• CI/PS (Before a device is placed on the market – Clinical Investigation and Performance Study)

Q2’ 2029: Article 123 (3) (e) MDR/113 (3) (a) IVDR

• Devices (Based on UDIs registered in EUDAMED) and
• Certificates (see above)

* For a brief explanation of EUDAMED modules refer to the below

Need help with Medical Electrical Equipment standards (60601/80601 series) including Safety/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.

Heads Up! – Updated 24 May 2021

Written by Bill Hardin and Leo Eisner

Thx for all the great support from the LinkedIn, RAPS Forum, the standards and test lab communities that have provided feedback on this post.  Turns out with all the good feedback we got from these communities we need to update this post as CISPR 11 Group 2 intentional radiators was included in the previous edition but you really need to be aware of RFID requirements.

The FDA has been insisting that medical device, IVD and even implanted medical device manufacturers meet AIM 7351731 RFID immunity testing as part of their 510k/PMA submissions.  This test is onerous since it includes RF immunity at levels of up to 54V/m, nearly twice the field strength (28V/m) that the IEC 60601-1-2 table 9 requires, and would often result in design changes to increase RF immunity.

From AIM 7351731:

IEC 60601-1-2:2020, edition 4.1, got fast tracked by the FDA since it contains new immunity tests (table 11 – RFID requirements based on AIM 7351731 standard values) that they want manufacturers to do before submitting. The FDA has been accepting the IEC 60601-1-2:2020 table 11 test in lieu of AIM 7351731 testing, which is very good news as there are only two AIM 7351731 frequencies to be tested instead of all the test frequencies and test levels of Table 3 of the AIM 7351731 standard.

This 2020 version of IEC 60601-1-2 is still about three years out from taking effect in EU (with no grandfathering allowed) unless your Notified Body may expect ‘State of the Art’ in a shorter time period (some do require this) or your company will go with ‘State of the Art’ which is a requirement of the EU MDR 2017/745 Annex I, Items 1 & 4, and per MDCG 2021-5, but FDA went first by Recognizing the standard at the end of 2020.

This blog previously erroneously stated that CISPR 11 Group 2 radiated emission limits had changed as part of the transition to IEC 60601-1-2:2020. They have not changed. So no redesign is needed for that but you still may need to redesign your product based on the RFID requirements.

Join the conversation on LinkedIn and add comments to the conversation there.

Confused by these EMC, standards or regulatory issues? 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. Bill Hardin is an EMC expert and a design expert that can help you thru the design process. 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/.

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

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

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

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

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

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

1 January 2019 is not far away and the 4th edition of the standard may have a significant impact on the design, testing and documentation of many medical devices that have not met this standard yet.  For the US (FDA), EU (CE Mark for Medical Devices), and Canada (Health Canada) this is the final transition date to meet this requirement.

When do we have to comply with IEC 60601-1-2 4^th edition?
The three countries/regions of the world (US, EU, & Canada) have synchronized the date of compliance to 1 January 2019.  This was not always the case as FDA modified their transition date several times before settling on this date.  Realize that most other countries are requiring 3rd edition and some are still back on 2nd edition of IEC 60601-1-2.  A brief summary by region is shown below:

USA – For new submissions to the FDA, compliance to the 4^th edition will be mandatory by January 1, 2019. The FDA now recognizes the 4^th edition and encourages manufactures to comply with the 4^th edition for new device submittals and this can be seen in the updated Final Guidance for Home Use Medical Devices that the FDA re-issued in November 24, 2014 and updated on August 8, 2016 to update the transition date of ANSI/AAMI/IEC 60601-1-2. During this transition period the FDA also will accept 3^rd edition of the standard as well up til December 31, 2018.

European Union – The Date of Withdrawal (DOW) which is the required compliance date of EN 60601-1-2:2014, is December 31, 2018.  The DOW date is the end of the grand fathering period for the previous version of the standard, EN 60601-1-2007 (third edition).  After that date, all devices including legacy devices sold to the EU must comply with the new standard.

Canada – In Health Canada’s List of Recognized Standards it states that until December 31, 2018 it will accept Declarations of Conformity to either 3rd or 4th edition of IEC 60601-1-2.  After which declarations of conformity to IEC 60601-1-2:2007 – Ed 3.0 will not be accepted.

Other Regions – The compliance dates are highly variable driven by other international standards and local regulations. For example, for a particular standard (Part 2 particular standards IEC 60601-2-XX or IEC/ISO 80601-2-XX) for a given device will most likely at this time reference IEC 60601-1-2, 4th edition if the country is using the most current IEC 60601-2-XX or IEC/ISO 80601-2-XX standard but otherwise may be referring to an older version of the IEC 60601-1-2.   Additionally, some countries will NOT accept the 4th edition at this time to further complicate this issue.

Please note that compliance dates of standards are driven by their national regulatory bodies (i.e. US = FDA, Canada = Health Canada, etc.) and are subject to change.

It is strongly recommended to comply with the requirements of IEC 60601-1-2 4^th edition for all new medical device designs going into the US, EU, and Canada.  You may still need to meet 3^rd edition, as well.  It really depends on what other countries you plan to sell too and your regulatory strategy.  We can help put a test plan and test strategy together to deal with testing to 3rd & 4th edition.

We have several EMC experts that can assist our clients with the transition to IEC 60601-1-2, 4^th edition as it is having a major impact on the design, testing and documentation required of most medical devices.  We are seeing signs of a new wave of projects related to IEC 60601-1-2, 4^th ed. and know that this edition will have a big impact on electrical medical devices.

The EMC services we can provide your medical device company are listed below, for your convenience, in addition to our other regulatory, product safety, engineering, and quality system consulting services.

EMC Services Available

• EMC Design – Review of PCB schematics & layouts, enclosure design, mechanical construction, internal and external cabling design, etc.
• Mitigations  – Problem analysis, prototype fixes, support design engineering on redesigns, EMC component vendor liaison, etc.
• EMC Witness Testing & Documentation – Perform testing oversight, generate test plans, review and generate test reports
  
• Risk Analysis – Work with the design and test teams to address Risk Management as required by IEC 60601-1-2 4^th edition
• EMC Standards – Guidance and interpretation of numerous EMC standards and regulations
• EMC Regulatory Engagement & Support – Provide support for FDA, FCC, Health Canada, KFDA, ANVISA, CE Mark and other agency approvals
• Medical Device EMC Labeling – Review accompanying documents for compliance to IEC/EN 60601-1-2 requirements
  
• Training – Training your staff on EMC design, testing, IEC 60601-1-2, 4^th edition, and differences between 3^rd and 4^th editions

Are you ready for these changes, do you have the bandwidth to deal with these changes?  We can help you with preparing for these changes and on your EMC regulatory strategy. Contact us at Leo at EisnerSafety dot com or call Leo at 503-245-6558 to arrange an EMC project to help support your medical electrical device EMC needs.