Leo Eisner, The60601Guy will be visiting London in October. You have the chance to sit down with me, The60601Guy, have a cup a coffee or a beer and talk IEC60601, design for compliance, and standards that apply to your device. I have time slots open on 7, 8, and 11 of Oct. Or join me for a dinner on the 8 or 11 Oct.

Meet me in London – I want to hear from you the week of 7 Oct. These two hour slots are limited before they are gone, 𝗯𝗼𝗼𝗸 𝗻𝗼𝘄 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁. I’d love to chat!

Let’s connect, and explore how we can support your company with our international team of compliance & regulatory experts from Eisner Safety Consultants. I’m eager to learn what you’re working on and how you’re driving change and innovation in the industry, and how we can support you to get you to market faster.

Let’s meet up! 𝗕𝗼𝗼𝗸 𝘁𝗶𝗺𝗲 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁.

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.

Learn from an 𝗶𝗻𝘀𝗶𝗱𝗲𝗿 𝗰𝗼𝗺𝗺𝗶𝘁𝘁𝗲𝗲 𝗺𝗲𝗺𝗯𝗲𝗿 that wrote portions of 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭-𝟭, 𝗲𝗱 𝟯.𝟮 𝗔𝗺𝗲𝗻𝗱𝗺𝗲𝗻𝘁𝘀 and is involved in the development of the Fourth Edition of IEC 60601-1. If you want to learn about these updates to the standard and the IEC 60601 Amendments Project – You’re in luck – Leonard (Leo) Eisner the “𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗚𝘂𝘆” from Eisner Safety Consultants partnered with Holly Rossington of BSI to present the webinar “Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers”

We answered some of the most pressing questions, such as:
• How North American medical device manufacturers can leverage the CB scheme and its benefits.
• Examples of medical devices BSI can certify.
• Key changes introduced in the latest edition of IEC 60601-1 (Ed. 3.2):
o Clause 7, Identification and marking.
o Clause 8, Protection against electrical hazards.
o Clause 13, Hazardous situations and fault conditions.
And lots more.

Watch to the end to get other valuable resources too!!!

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 meeting 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.

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.

The FDA in a little over a month on 30 May 2022 (that is swift) has updated the Recognized Consensus database for the AAMI 60601 Amendmended Standards that are referenced in my previous post of May 13, 2022. The AAMI standards were published in late March 2022.

Not each Recognition was updated in the same way. Let me explain:

FDA Recognition # 19-46 ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] – the ANSI AAMI ES60601-1 AMD2:2021 is identical to Amendment 2:2020 of IEC 60601-1:2005 (post corrected 13 June)

FDA Recognition # 19-47 ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021] – the ANSI AAMI HA60601-1-11 AMD1:2021 is identical to AMD1:2020 of IEC 60601-1-11:2015 (post corrected 13 June)

FDA Recognition # 19-36 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] –  the ANSI AAMI IEC 60601-1-2:2014 Including AMD 1:2021 is identical to AMD1:2020 of IEC 60601-1-2:2014

FDA Recognition # 5-131 ANSI AAMI IEC 60601-1-8:2006 and A1:20012 [including AMD2:2021] – the ANSI AAMI IEC 60601-1-8:2006 and A1:20012 including AMD2:2021 is identical to Amendment 2:2020 of IEC 60601-1-8:2006

FDA Recognition # 19-39 ANSI AAMI IEC 60601-1-12:2016 [Including AMD 1:2021] –  the ANSI AAMI IEC 60601-1-12:2016 Including AMD 1:2021 is identical to AMD1:2020 of IEC 60601-1-12:2014

Need Help?

Need help with 60601 standards (Medical Electrical Equipment), work thru 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. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

After a delay of over a year since the original US Technical Advisory Group IEC/SC62A & specific technical committees — Electrical Safety, Electromagnetic Compatibility,  Alarms, and Home Care and EMS Environments committees — vote and an additional vote for each of the documents noted below AAMI and ANSI finally has approved these Amendments in January and February 2022. They were all published in April 2022 (correction late March 2022). The Amendments are all identical adoptions of the IEC versions which were originally issued through IEC during June – Aug of 2020. The standards are available on the AAMI standards db and at the AAMI store (if your an AAMI member log-in for your member discount). The links below are to the AAMI store version of the standard which is just the latest Amendment only.

You’ll want to know about this as the FDA will Recognize has Recognized (see post on Recognition of these standards) all of these Standards as soon as they can get them added to their Recognized Standards db probably before the next full publication of the db.

• ANSI/AAMI ES60601-1:2005/A2:2021  Medical electrical equipment—Part 1: General requirements for basic safety and essential performance— Amendment 2 (Amendment 2 to IEC 60601-1:2005)

• ANSI/AAMI/IEC 60601-1-2:2014/A1:2021  Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests, Amendment 1 (Amendment 1 to IEC 60601-1-2:2014)

• ANSI/AAMI/IEC 60601-1-8:2006/ A2:2021 Medical Electrical Equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, Amendment 2 (Amendment 2 to IEC 60601-1-8:2006)

• ANSI/AAMI HA60601-1-11:2015/A1:2021 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, Amendment 1 (Amendment 1 to IEC 60601-1-11:2015)

• ANSI/AAMI/IEC 60601-1-12:2016/A1:2021 Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment— Amendment 1 (Amendment 1 to IEC 60601-1-12:2014)

Need Help?

Need help with 60601 standards (Medical Electrical Equipment), work thru 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. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

Joe Hage graciously invited me to present on July 30 to his MDG premium group on “IEC 60601 Amendments & What’s in the future for Medical Electrical Equipment”. We had a great conversation with about 35 or so people from around the world. They were from Ireland, the Netherlands, India, the US, and elsewhere in the conversation, with questions throughout and at the end too.

I included some new information about the FDA ASCA Pilot Program (new lab info) and also some about the status of some of the Amendment standards and where the US and EU standards are at in terms of adoption.

Enjoy the presentation. It’s at https://youtu.be/yS0xfFX0VpU – MDG Premium’s special YouTube Channel

By the way I recently joined the MDG premium group and you should too. It’s a great way to meet others in the industry and trade ideas and ask questions of experts in the field.

Need help with the IEC 60601 Amendments, work thru strategic planning for your medical electrical product lines, need support when FDA or a regulator ask 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. 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/.