The IEC 60601-1 4th edition is organized by hazard, not by clause. That is not a cosmetic change, and it decides how you read every draft that follows.

Edition 3.2 of IEC 60601-1 is organized by clause. You want leakage current, you go to Clause 8. You want mechanical hazards, you go to Clause 9. You want excessive temperatures, you go to Clause 11.

The 4th edition is not built that way, and the difference is not cosmetic. It changes what you look up, how you scope your project, and what a gap analysis against it actually has to do.

Here is what sits underneath the change, why it was made, and how to read the drafts without getting lost in them.

The two documents almost nobody reads

There are two public specifications behind the 4th edition. Both are publicly available; both have been sitting on the IEC servers for years, and almost nobody outside the working groups has opened them.

The Architecture Specification (V3.0) was approved on 5 May 2020, and it sets the philosophy for the 4th edition. Sharpen the focus on basic safety and essential performance. Clarify the concepts. Give a rationale for every requirement. Push the standard toward discrete, atomic, design-ready requirements written in consistent terminology (IEV 60050-880), rather than prose that has to be interpreted before it can be applied. It aligns the standard with the IMDRF Essential Principles (N47 and N52) so that it is regulatory-ready. And it looks past publication to a machine-readable database version of the standard.

I wrote about where all of this came from, including the 2015 SC 62A decision in Kobe that started it, in a LinkedIn post on 20 July 2026.

The Design Specification Outline followed on 30 November 2023. It is the road map that implements the architecture: which parts of the 3rd edition map to which working group, what other standards feed in, what is new, and what is being removed. It is the document that actually carves the work into the twelve hazard concepts. It also merges the collateral standards into the general standard, and that merge is a large part of why roughly 500 pages becomes more than 1,000.

Both specifications are on the IEC servers and free to download:

• Architecture Specification (2020)
• Design Specification Outline (2023)

The Design Specification has evolved since these documents were released, shaped by AG 50 editing team feedback. They are still the best available window into why the edition is shaped the way it is. If you are going to read one thing before you read a fragment, read the Design Specification Outline.

Why hazard, and not clause

A clause-organized standard answers the question what does this clause require? A hazard-organized standard answers a different question: what can hurt someone, and what do we do about it?

That matters for three practical reasons.

It matches how risk management already works. IEC 60601-1 has been built on ISO 14971 since Edition 3.0. That is not new in the 4th edition, and anyone telling you the risk-management foundation is the change has it wrong. What is new is that the structure of the document now follows the same hazard logic your risk file already uses. The standard stops making you translate between two organizing principles.

It stops the same hazard being addressed in multiple places. In Edition 3.2, thermal considerations show up in the enclosure clause (13.1.2), in the single-fault clause (13), in the applicable components clauses, and so on. Grouping by hazard forces the working groups to write each hazard once and to keep cross-references few and deliberate. The Architecture Specification asks for exactly that: limited cross-referencing, used on purpose rather than by accident. The move runs the other way too. Construction and ME systems (MES) are clauses of their own in Edition 3.2, Clauses 15 and 16. In the 4th edition they are not clauses at all. Those requirements are distributed across the standard, into the hazard fragments wherever they apply.

It makes the requirements addressable. A requirement written as a discrete, traceable statement can be tagged, filtered and pulled into a requirements database. A requirement buried in a paragraph of qualified prose cannot. That is the quiet ambition of the architecture, and it is the reason the drafts read differently from Edition 3.2 the moment you open one.

The map: twelve fragments, twelve working groups

The mapping is mechanical. Fragment N is written by Working Group 36 + N.

For current draft status of each fragment, see the fragment table in the 4th-edition hub, which is kept up to date as drafts circulate.

One reader described the map as a table of contents for the future standard. That is close to right, with one caveat worth holding onto: it is a table of contents for twelve documents that do not yet read as one. Making them read as one is the job of the merge, and of AG 50.

AG 50, and the problem of twelve authors

Twelve working groups drafting in parallel produce twelve dialects. One group writes “verify basic safety.” Another writes out the specific tests. One uses a term the way its own sector uses it; another uses the same term to mean something adjacent. Left alone, you get a standard that contradicts itself in the seams.

AG 50 is the editing team that stops that. It is made up of the leadership of all twelve working groups plus the project leadership, and it meets weekly. Its output is consistency: shared terminology, a shared style guide (the Design Specification, with a great deal more added), agreement on where a requirement belongs when two groups both have a claim on it, and a set of drafting rules that keep the fragments compatible before anyone tries to merge them. That work can reach into the starting concepts behind requirements, not only the words used to express them.

That is unglamorous work, and it is the reason the edition is slow. It is also the reason the merged document will be readable at all.

What CD1, CD2 and CD3 actually mean when you are reading a draft

This is the practical part, and it is where most people reading fragment drafts go wrong.

A committee draft is a snapshot, and it is frozen the day it is circulated. Nothing is edited into it afterwards. Here is the sequence, because it is the part that catches people.

It runs in five stages, and Fragment 1 makes a clean worked example because every document in the sequence exists.

1. The CD is circulated to the National Committees. Fragment 1’s first committee draft went out as 62A/1628/CD.
2. The comments are compiled into a CC. The national committees and their experts read the draft and file comments, and the comments are gathered up and circulated back as a compilation of comments. For Fragment 1 that was 62A/1656/CC.
3. The working group resolves them. Accepting some, partially accepting others, editing others, and rejecting others, often over several months or more. Nothing circulates while that is going on.
4. The resolutions are issued as a revised CC. In this case 62A/1656A/CC, carrying the full resolution of every comment, and it goes to the National Committees.
5. The next CD circulates with the resolved text in it. For Fragment 1 that was 62A/1759/CD, the CD2 that is open for comment until 16 October 2026. It is built from 62A/1628/CD and 62A/1656A/CC together: the previous draft, plus what the working group decided to do about every comment on it. 16 October is the IEC date, not yours: see the comment windows are the part people miss.

Two things follow from that sequence, and they pull in different directions.

The resolutions are not secret. The revised CC goes to the National Committees, so if you are active in yours, or you ask someone who is, you can find out what happened to a comment without waiting a year for the next draft. Note what that means: none of these documents sit on the open web. Every one of them, the CDs included, reaches you through your National Committee. That is a good reason to be connected to yours rather than watching from outside.

But the draft itself never changes. So there is still a long stretch where the newest circulated draft (CD, CDV or FDIS) is at the same time the most current draft available to you and materially out of date. A requirement you read in it may already have been resolved into something else. That is not a failure of process. It is how consensus standards development works, and it is why the draft in your hands has to be read as a direction of travel rather than as the answer.

That describes what circulates. The work itself lives somewhere else. Drafting happens in the OSD, the IEC’s online standards development database, and it is there from the start of a project through to publication of the standard. This is the database-driven way standards are now developed: the text is written and revised in the OSD, and the comments and the edits made in response to them are tracked in it as the project moves. So there is a continuous record of how a requirement got to where it is. Committee members can see it. If you are not on a working group you cannot, so the practical thing you can do is keep track of which stage has actually been circulated for each fragment, CD, CDV or FDIS, and read whatever you are holding knowing the work has carried on since it was frozen.

So when you read a fragment:

• CD1 is a first pass. Treat the direction as real and the specifics as provisional. Do not build a design decision on CD1 wording.
• CD2 has been through a full round of National Committee comment and resolution, so the thinking is more settled than CD1. It is still a committee draft.
• CD3 is unusual. Fragment 4 is on CD3 and will probably be the only one in the IEC 60601-1 4th edition project to run a CD3. For most fragments the intent is to publish a CD2, take the comments and move on toward the merge CDVs, which will be AG 50’s responsibility.

The thing that surprises people about the page count

Edition 3.2 runs about 500 pages. The 4th edition is heading past 1,000, and the number gets quoted as though the requirements have doubled.

They have not, quite. Two things inflate it.

First, Clause 3, terms and definitions, repeats in every fragment. Each fragment has to stand alone as a readable draft, so each carries its own definitions. That duplication disappears at the merge.

Second, the edition carries far more supporting material than Edition 3.2 ever did. The Architecture Specification requires each requirement to be accompanied by guidance, rationale, and an explanation of what changed from Edition 3.2. The old IEC TR 62348, which was a standalone document explaining the changes, is now built into an annex per subclause. That is genuinely useful to a reader, and it is a lot of pages.

It is also the single biggest reason the project takes as long as it does. Rationale was never written for every subclause of Edition 3.2, and writing a differences explanation for every subclause of a thousand-page standard is a very heavy lift.

How to actually read this thing

Seven steps, in order. Part of this came from a mentor of mine, and the sequence he drilled into me has held up ever since. Read the terms and definitions first, because you have to understand the language of the standard before anything else in it makes sense. Then read the rationale, because that is where the background and the context sit, and the more of it you carry up front, the easier the implementation gets later. Then go back and reread the terms and definitions, which land differently once the rationale has given them weight. Only then get your hands dirty in the requirements themselves.

1. Start with the Scope. Understand the scope of the standard and how it applies to your products: what is in scope and what is not. More products have been brought into scope under the broader scope that has been written, including SaMD. Do not assume that because the current edition did not reach your product, the 4th edition will not either.
2. Read the terms and definitions. Clause 3 of Fragment 1. Check them against the current IEC 60050-880 and any amendments, including the latest drafts where a published version has not caught up. Fragment 1’s terms should sync with 60050-880, but depending on which copies (Frag 1 and IEC 60050-880) you can get hold of they may not, so work from the most recent versions available to you.
3. Read the rationale annexes. This is where your gap analysis should start. The committee’s own “what changed and why” statements are a better source for it than reconstructing the diff yourself, and they are the closest thing the 4th edition has to the old IEC TR 62348, which is now built into an annex per subclause.
4. Reread the terms and definitions. Now that the rationale has given them context. This is the step people skip, and it is the one that makes the rest of the reading go faster.
5. Then Fragment 1, the general requirements. These decide what applies to you at all. Use specification drives what is in scope. Categorization points you to the requirements that apply and lets you set the rest aside. Nothing downstream is scopeable until this is done. This is also the point to start putting your conformity evaluation plan together, and you can do that today rather than waiting for the 4th edition: see what part of Fragment 1 is critical to start early.
6. Then read the fragments your device clearly touches. For most devices that is most of them, to differing degrees. Only ionizing radiation is genuinely device-specific.
7. Reread the rationale annexes. A second pass, now against the requirements that apply to your product(s).

What part of Fragment 1 is critical to start early: the plan and the file

Start with Frag 1 and you arrive, fairly quickly, at Clause 8 of Frag 1. It is called Conformity evaluation, and it is a clause in its own right, sitting after use specification and categorization. This is the part of the 4th edition that changes how you work rather than what you build, and it is the part you can start on today.

Two documents sit at the centre of it, and one contains the other.

The conformity evaluation plan is where you decide, in advance and in writing, what compliant means for your device: which requirements apply, what evidence shows each one is met, and who owns that evidence. The conformity evaluation file holds the plan and it holds the results. That is the whole shape of it:

The planning side is where the work sits. The plan pins down how your device is categorized, what your use specification says, which clauses you are evaluating and which you are not, what samples you will use and the worst-case test scenarios, and what order the evaluations run in. That is not a small job. It is also the job that decides whether everything downstream holds together, because a scope nobody agreed at the start is a scope everyone inherits later.

The record side is a chain, and the chain is the point:

Pull any link and the next one should be right there. That is what a reviewer is checking for when they ask the question you did not prepare for.

Two things surprise people about this.

None of it has to live in a new set of binders. The draft is explicit that the records forming the file may form part of other documents and files you already keep, and it names the risk management file and the usability engineering file as examples. Most organizations already produce or contract most of this evidence: safety and EMC reports, risk analysis, usability, software, design reviews, labeling assessments. What is usually missing is the plan that ties them to requirements.

It is not an invention of this committee. The Fragment 1 draft cites the FDA ASCA programme, the Accreditation Scheme for Conformity Assessment, in its bibliography, and attributes part of the specific-plan requirements to it directly. If ASCA is familiar to you, a good deal of this will be too. ISO/IEC 17025 is cited alongside it for third-party evaluating organizations.

And nothing in Edition 3.2 stops you working this way today. Edition 3.2 has no explicit requirement for a conformity evaluation plan, which is a different thing from prohibiting one. The teams already working this way have an easier time on every test project submission, and they will not be building this from nothing in the year they are trying to launch against the new edition.

The short version of this section ran on LinkedIn on 25 August 2026, where the discussion in the comments is worth reading on its own.

The comment windows are the part people miss

Every one of these drafts is open for a defined period, and then it is not. If you are not one of the experts writing the document, the comment window is your route into the text.

Two IEC dates worth having on a calendar as of 31 August 2026: Fragments 2, 4 and 10 close on 25 September 2026, and Fragment 1 closes on 16 October 2026.

The current status of every fragment, and the deadlines as they change, live on the 4th-edition hub.

Key themes: IEC 60601/80601, IEC 61326-2-6, ISO 15223-1 A1:25, & ASCA considerations

In late December 2025, the FDA expanded its Recognized Consensus Standards Database, adding more than 100 new or updated standards. Some are eligible for use under the ASCA Program, while others carry important implications for design, testing, labeling, and overall regulatory strategy.

Regulatory expectations around standards are shifting earlier in the product lifecycle. Standards are no longer something teams can simply “handle at test.” Reviewers increasingly expect standards interpretation, risk decisions, and test strategies to be visible and justified during design reviews and technical documentation development. This reinforces why understanding not just which standards are recognized, but how they are recognized and applied, matters more than ever.

What the latest FDA update included

The scope of this database expansion spans a wide range of medical device technologies, including medical electrical equipment, IVDs, software-driven devices, imaging systems, interoperability standards, and labeling-related standards.

Beyond simply identifying newly recognized standards, the changes highlight how recognition status, ASCA eligibility, and extent of recognition can materially affect how conformity is demonstrated, how evidence is presented, and how submissions are reviewed.

Over the past year, I’ve been sharing what I’m seeing based on feedback gathered from many sources, including my Eisner Safety Consultants experts and discussions across the community with regulators, standards developers, test labs, and manufacturers. The goal is practical clarity: what changed, what it means, and what teams should do next as they navigate evolving standards expectations and regulatory requirements.

IEC 60601 / 80601 standards in the update

For manufacturers of medical electrical equipment, the December 22, 2025 update includes several standards from the IEC 60601 and 80601 series. These standards remain central to demonstrating basic safety and essential performance for medical electrical equipment. However, recognition alone does not mean every clause or requirement is fully accepted without qualification.

Standards called out in the December 22, 2025 update
(from the FDA database extract)

EMC context within the IEC 60601 / 80601 framework

IEC 60601-1-2 remains the primary EMC standard within the IEC 60601 series. However, other IEC 60601 standards can and do include EMC-related requirements. Applicability must be assessed standard by standard, based on the specific requirements of each applicable document.

This context becomes especially important when considering how EMC expectations are addressed across different standard families, including IVD-specific EMC requirements discussed next.

IVD EMC and IEC 61326-2-6

A notable change reflected in the FDA Recognized Consensus Standards Database is the inclusion of IEC 61326-2-6 Edition 4 as a Recognized Consensus Standard, with ASCA eligibility under the ASCA Program, effective July 28, 2025.

This is significant because IEC 61326-2-6 is the primary EMC standard used to demonstrate electromagnetic compatibility for IVD medical equipment, and its inclusion under ASCA directly affects how EMC conformity evidence may be presented in FDA submissions.

However, ASCA eligibility alone does not guarantee streamlined review.

For manufacturers intending to rely on ASCA pathways for IVD EMC:

• Test lab scope must be verified as active for the specific standards and applicable editions being claimed.
• If a standard or edition is not within a laboratory’s ASCA-accredited scope, manufacturers cannot rely on an ASCA Summary Test Report for that standard.
  • In those cases, full EMC test reports remain necessary, and FDA review timelines are typically longer.

As of early January 2026, there are no ASCA-accredited laboratories that reflect IEC 61326-2-6 Edition 4 within their active scope. This creates a practical timing and planning consideration for manufacturers preparing IVD submissions that intend to leverage ASCA.

This gap does not change the applicability of IEC 61326-2-6 itself, but it does affect how conformity evidence can be packaged and reviewed until laboratory scopes are updated.

ISO 15223-1 Amendment 1:2025 and labeling implications

Authorized Representative symbol changes and labeling impact

ISO 15223-1 Amendment 1:2025 introduces a substantive correction to the requirements for the Authorized Representative symbol that has direct regulatory and labeling implications across multiple markets.

This change is implemented through a revision to Clause 5.1.2, which governs how the Authorized Representative symbol is applied.

Clause 5.1.2 – prior to Amendment 1:2025

“This symbol shall be accompanied by the name and address of the authorized representative, adjacent to the symbol.”

Under this wording:

• The symbol itself did not explicitly encode the jurisdiction
• The convention of using “EC REP” persisted in practice, even after the transition from the MDD & IVDD to EU MDR and IVDR
• This created ambiguity for non-EU markets and for products marketed globally under different regulatory frameworks

Clause 5.1.2 – after Amendment 1:2025

“The [XX] text of the symbol shall be replaced by either the two-letter country code or the three-letter country code defined in ISO 3166-1 or other text required by the authority having jurisdiction.

This symbol shall be accompanied by the name and address of the authorized representative adjacent to the symbol.”

Key changes introduced by this amendment:

• The Authorized Representative symbol must identify the jurisdiction represented
• The jurisdiction identifier is no longer implicit or assumed
• Country-specific representation is now explicitly required using ISO 3166-1 codes or authority-mandated text

This change aligns the symbol requirements with:

• EU MDR and IVDR expectations for EU Countries
• Non-EU regulatory frameworks that require local authorized representation
• Global labeling clarity for multi-market products

Practical application of the revised requirement

International example

Used for countries outside the EU, such as Switzerland or the United Kingdom.

Examples:

• CH REP for Switzerland
• UK REP for the United Kingdom

Convert from EC Rep to International two-letter country code Authorized Representative Symbol

EU example

Used for EU Member States.

Convert from EC Rep to EU Rep Authorized Representative Symbol

Labeling and change-control implications

Symbol changes cascade into artwork, IFUs, packaging, and labeling change control. This affects and has significant impact on:

• Device labels
• IFUs
• Packaging artwork
• Labeling control procedures

These changes must be assessed and implemented through formal labeling change processes, not treated as isolated graphic updates.

Join me, Leo Eisner, The IEC 60601 Guy, as I lead an interactive and fun workshop at the 10X Medical Device Conference in Newport Beach, Ca on May 7 – 8, 2025. Turn Medical Device Standards into Your Competitive Advantage, and discover practical strategies to leverage standards, avoid costly errors, and accelerate your product development cycle.

Don’t make the 5 costly mistakes companies make with Medical Device Standards. Learn from the IEC 60601 Guy himself.:

• Late Identification of Applicable Standards: Leads to expensive redesigns and delayed timelines
• Ignoring Expert Standards Guidance: Results in regulatory rejections and costly resubmissions
• Unprepared Risk Management File for Testing: Risks unnecessary costs due to lack of strategic planning for compliance.
• Unprepared Regulatory Submissions: Leads to costly setbacks and market-entry delays
• Underestimating Education and Training: Creates knowledge gaps, increasing errors and compliance risks.

I want to thank Sean Smith and his team from 10X for all his help and dedication for putting on this event. He is doing an amazing job and please contact him if you are interested.

Need help with standards?

We provide support for your design and development process for regulatory submissions.? Eisner Safety Consultants can help by

• Assisting with strategic compliance planning for your medical electrical product lines,
• Providing regulatory support when FDA or a regulator asks technical questions on your submission.
• Identification of applicable standards, laws, regulations, guidances, and directives up front to support your design process effectively.
• Design Documentation Reviews providing expert analysis supporting the design development process to avoid unnecessary design and development delays.
• We provide EU, US, and other countries regulatory requirement reviews of standards, laws, directives, and guidance.
• Providing support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more.
• Interfacing with test houses for medical safety, EMC and arrange other testing.

Feel free to schedule a web meeting with Leo or contact us.

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.

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.

The FDA on May 30, 2022, same day as when the recent AAMI 60601 Amendments were Recognized, added the Interpretation Sheet 1 (ISH1) – Amendment 1 – on Essential Performance (Clause 4.3) and Single Fault Condition (Clause 4.7) based on IEC 60601-1:2005+A1:2012 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance to:
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] and
FDA Recognition # 19-4 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text).

ISH1 was added to both FDA Recognitions # 19-46 & 19-4 as a “Relevant FDA Guidance and/or Supportive Publications” not as an independent Recognized Consensus Standard.
The ISH1 was Issued 2021-03 by IEC. One reason why FDA probably didn’t include the ISH1 as a Recognized Consensus Standard is because it isn’t an ANSI and AAMI approved standard. A blog post on the ISH1 when it was issued can be viewed here.

The FDA has been reviewing Essential Performance (EP) during submission for many years, since the publication of the 3rd edition of IEC 60601-1:2005 and their Recognition of ANSI AAMI ES60601-1:2005. It was even discussed during the expert panel, May 2018, at the ASCA Workshop, which I was the expert on EP on the panel. So, expect that FDA will review your submission for EP both for the safety and the EMC side of your testing.

Questions you need to consider early in the product development:
* have you identified the clinical functions of your device that are EP,
* have you started your EP analysis,
* has the EP analysis been fully connected with your Risk Management File,
* have you written your EP so it is capable of being tested for the safety and EMC which will be tested differently,
* and so much more…

One of the next steps out of the generation of the ISH1, as noted in the blog post on ISH1, was the formation of the Project Team PT 62A-1 with a goal to generate a technical report IEC TR 60601-4-6 as a guidance document on Essential Performance. PT 62A-1 has been meeting since February of 2022 and been trying to work on figuring out how we want to provide guidance to manufacturers, test houses and regulators on Essential Performance and Faults related to EP. The main reason for this is that we have seen there is so much confusion on this subject by some manufacturers, test houses and regulators and we want to provide a document that will provide a consistent guidance on the concept of Essential Performance and Fault Safety related to EP.

Need help with Essential Performance, 60601 series 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.