Harmonization date of IEC 60601-1 , 3rd Edition

New version of the CENELEC Q&A on 60601 at the CENELEC website:

http ://www .cenelec .eu/Cenelec/CENELEC+in+action/Horizontal+areas/ICT/Collateral_standards_under_MDD_AIMD.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

Hello,

FDA has recognized 3rd Edition of 60601. The transition date of withdrawal of 2nd edition is June 30, 2013.

Here is the link.

Recognized Consensus Standards

The actual Federal Register documents were provided by another forum member in this thread:
:
FDA Federal Register - 2013 date for 60601 3rd Ed?

-Tara

Hi all
See the new list of harmonized standards for the medical devices directives published in the Official Journal of the European Union on 7 july 2010

directive 93/42/EEC as amended by dir 2007/47/EC medical devices
http :// eur-lex. europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:183:0015:0044:EN. PDF - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

including the Date of cessation of presumption of conformity of superseded standard for the EN 60601-1 :
1. june . 2012

Regards

Xavier

Recognition of 60601-1 Third Edition By Department of Labor May Not Occur -

IEC 60601-1 is a voluntary standard for medical device regulatory compliance, but it is mandatory for meeting US and Canadian regulations pertaining to Occupational Safety and Health that concern worker safety, not patients. The Department of Labor regulation 29 CFR 1910.303 requires that “electrical equipment be approved”. Meaning tested by a third party Nationally Recognized Testing Labs (NRTL). Whereas the FDA, Europe and Health Canada have made nearly all standards voluntary, the Department of Labor fears it could unintentionally make the Third Edition mandatory. This has caused the Department of Labor to pause on the idea of accepting the Third Edition of 60601-1 in place of the 2nd edition

I called the Department of Labor and spoke with one of their officials. They told me that although they are getting phone calls regularly asking them to recognize the Third Edition of 60601-1, especially since the FDA has recognized it recently, they are not so willing to recognize it.

It was explained to me this way. The regulation concerning electrical equipment in 29 CFR 1910.303 is meant to be a "third party approval”, where the decision as to whether the product is “safe” is wholly determined by the third party (NRTL). The department of labor explained that the Third Edition of 60601-1 relies too much on the manufacturer's own conclusions, since the ISO 14971 Risk Management File part of Third Edition Compliance is created by the manufacturer and not the Nationally Recognized Testing Lab. In effect, if a medical device manufacture erroneously estimates that a risk is low or benefit too high, they could erroneously justify an exclusion from normal testing criteria and the NRTL would be obliged to accept it, as that is how the Third Edition was intended to be applied. This is why the Department of Labor is dragging their feet. The Risk Management approach undermines the intention to maintain an entirely independent third party assessment of worker safety.

There is also a concern that the Department of Labor's third party system for worker safety is being used to assess patient safety, which is not their intent. As patient safety is not intended to be regulated by the Department of Labor, they are aware that an extraordinary regulatory burden is being placed on industry without having an alternative to the Third Edition to meet the regulatory requirements of 29 CFR 1910.303.

After speaking with two of the major NRTLs about the cost of getting products evaluated to 29 CFR 1910.303, I learned that indeed, they all plan to evaluate anything that is a "medical device" to the Third Edition of 60601-to meet 29 CFR part 1910.303, once the Department of Labor recognizes it and makes the 2nd edition obsolete. There is no other standard for worker safety that they would allow for use as an alternative for meeting the Department of Labor requirement.

The same two NRTLs also estimated that the cost for assessing to the Third Edition of 60601-1 will rise 50% or more, above the cost of assessing to the 2nd Edition of 60601-1. This is frightening, considering these costs have already risen 400% in the last 10 years.

I’ve also learned that Congress is now aware of how these otherwise hidden regulatory costs are creating concerns for industry, and may consider whether a regulatory change is needed to ensure industry can choose to use standards for compliance with 29 CFR 1910.303 that more narrowly address protections for worker and workplace safety. The Department of Labor told me it would take an act of Congress to make such a change. It will be interesting to find out what Congress is actually doing. Does anyone know?

Hello Grant!

Great comments, and i would like to hear the opinion from cove users which are manufacturers about this...

Just some more comments on the use of the 3rd edition with NRTL/SCC marks:

As one earlier poster noted, the NRTL scheme does not cover patients. Actually I found one interesting reference under OSHA 29 CFR:

1910.5(d)

In the event a standard protects on its face a class of persons larger than employees, the standard shall be applicable under this part only to employees and their employment and places of employment.
​

Click to expand...

There is also a significant scope limitation to electric shock and fire for Canadian SCC marks, which can be derived from the scope statement in the Canadian Electrical Code, under which SCC marks operate.

An NRTL/SCC mark is also a private mark, so it is possible for the company that issues the mark to go beyond the NRTL/SCC scope limitations. But that is a private choice, and any company that issues these marks should be careful to avoid implying that have to check particulars, collaterals beyond the NRTL/SCC scopes. Of course, with the way medical standards are moving it's easy to get confused, but with good staff training the scope limitation should be clear to all.

This scope limitation applies even now (for the 2nd edition) and helps to explain why EMC, biocompatibility, PEMS and other aspects are frequently excluded from test reports.

It is important to recognise that test labs that go beyond the NRTL/SCC scope are doing so in an unregulated environment. To put it less formally, they are a law unto themselves, which is always a bad situation in the long run.

In the short term it might seem attractive for a manufacturer to ask NRTL/SCC labs to produce reports to particular and collateral standards that can also be used in regulatory applications. But it is only a matter of time before incidents in the market put the laboratory qualification issue in focus. Manufacturers may suddenly find all those reports they paid for to be worthless, and with little recourse, since it is responsibility of the manufacturer to verify qualification before using a subcontractor.

In the long run it may be insurance that clips the wings of NRTL/SCC labs working in the medical field. Once the legal department gets wind of kind of reports that labs are issuing, they might question the wisdom of doing so and start to look more closely at NRTL/SCC lab's true competence in the functional and clinical side of the medical device.

Re: Harmonization date of IEC 60601-1 , 3rd Edition
________________________________________
Thanks Peter,

In my view, I cannot believe medical device industry sits so quietly by while
It's very helpful to get the facts straight about what NRTLs can do, should do, and should not be allowed to do. This is all good information. Your research to the point in the OSHA reg is very much appreciated. I do think standards will continue to play an important role in free trade and getting device clearance, but to me, this Third Edition approaches like a doomsday meteor in 2012, it is the one exception as to why I think we should like standards.

Regulators simply do not have the technical expertise to make judgment calls regarding the safety of the 5000+ different types of medical devices that are supporting our healthcare system. They would certainly struggle with the Safety, EMC and many other types of testing, for lack of facilities, equipment, maintenance and technical expertise. Furthermore, would we really want regulators testing our devices? In some countries, corruption is still a concern. People still "buy" illegitimate certificates.

I personally support some third party testing, especially as I become more familiar with how the International Accreditation Forum and International Laboratory Accreditation Cooperation are edging certification toward harmonized levels of credibility. Most importantly, they breaking down more technical barriers, as IAF and ILAC Multilateral Recognition Agreements further expand to cover a wider scope of standards and certification activities.[/B] "Certified once, accepted everywhere" can only be achieved through the use of international standards and the technical expertise applied through the accreditation body/certification body chain. This is a topic of its own, but surely IEC 60601-1 Third Edition is tied to mutual global acceptance (concerning patient safety). In affect, it makes it more likely to be required for exporting globally.

NRTL and Insturance (Underwriting) Companies
Insurance companies, for lack of their own expertise, have relied on standards and a certification body's assessments of product or management system certifications for years. In fact, Underwriter's Laboratory's has its origins in insurance underwriting. The FDA's use of NRTL’s to test to standards, just makes good sense.

Pseudo-Self Declaration Under Third Edition
Although "self declaration" is widely accepted for lower risk products, where credibility matters most, self-declaration is not used at all. That is why OSHA doesn't like the Third Edition. The Third Edition places pseudo-self declaration into the third party system, by inculcating ISO 14971 standard into the evaluation, giving the manufacturer, NOT the NRTL, primary responsibility for identifying and mitigating the medical device's risk, even to the point of excluding tests or test criteria! Although this had to be done, since an NRTL can't possibly have the expertise to understand the "indications for use" and how to mitigate risks associated with it. Howeve, this give an NRTL certification the appearance that the NRTL has cleared all aspects of the device's safety.

The IEC 60601-1 Third Edition will now allow the Office of Device Evaluation at FDA and the Manufacturers of high risk, highly complex devices, to shift more of the burden of decision making onto the NRTL. Instead of the public pointing the finger at the manufacturer or FDA for clearing a device that is learned later to have caused death or serious injury, the manufacturer can point to FDA and FDA can point at the NRTL. Even the NRTL's have a way out, since they could blame the manufacturer for not properly identifying the particular risk in their Risk Management System, since an oversight in applying ISO 14971 under 60601-1 remains the primary responsibility of the manufacturer. In affect, an inneffectual application of the Third Edition will likely center the blame of death or serious injury on both the manufacturer and the NRTL. So the blame goes round and round and the lawyers can pick from more targets.

With the potential to shift so much blame around, I think all the parties that wrote, recognize or use the Third Edition have to be pretty pleased with the outcome. I think the NRTL's are slowly discovering they they are being used beyond their skillset, since they cannot possibly know how to handle risks related to "intended use" and "essential performance".

Unfortunately the NRTLs are not the ones to suffer most, since the "average Joe" medical device manufacturer, who provide 90% of the medical devices (that are not high risk); are carrying the bill. By In 2012, we will be doubling our testing costs with NRTLs, to satisfy Patient Safety requriements, that are clearly beyond the scope of the OSHA reg you cited, and the NRTLs expertise to properly assess.

I think the scores of lawyers working at the NRTLs had better shift their focus from protecting their "marks" to protecting their labs from patient injury and death claims.

I would certainly encourage the development of test labs that are properly qualified and equipped to handle the functional side of medical device technology, and operating under a lab accreditation scheme that really checks the qualification. In my experience, truly independent third party tests, away from the rough and tumble of the design world, yields extremely valuable information for the manufacturer.

However, it is not cheap and takes time. The tests are individual, and performance and functional requirements have tight limits, so there is much more discussion on test methods and interpretation of results. So for me it's something should remain voluntary, with the manufacturer having the final say when to use an external lab and what to do with the test results.

That's what concerns me about NRTL/SCC labs trying to include performance and functionality in a de facto mandatory environment. Obviously the labs do not have the capacity to cover performance and functionality, since their core competence is electric shock, fire, basic mechanical hazards. So they will rely on the manufacturer's data. While some manufacturers do establish competent internal labs which are impartial from the designers, most do not. What this means is that NRTL/SCC labs usually end up rubber stamping the designer's tests, which gets us back to the same rough and tumble world far away formal laboratory process.

Designers are doing a great and tough job but are not always the best for reliable, methodical laboratory testing. They make assumptions, short cuts, skip requirements they think are not important, and need to answer to the sales department that is screaming to get the product released. All perfect reasons why impartial tests are so valuable, and why NRTL/SCC lab are exposing themselves to huge amount of liability by rubber stamping the designer's work.

Ideally I would like to see manufacturers improve their verification processes, moving towards a model of in-house independent verification, or outsourced to properly qualified laboratories for smaller manufacturers or in special cases.

And, let's not forget the one person this is all meant to help: the patient. What benefit is there for the patient for an inexperienced NRTL/SCC test engineer to come in and rubber stamp the designers work? The test lab gets testing fees, the manufacturer gets their testing endorsed. They are both happy. But the patient? No benefit that I can see.

Well said Peter,

On all counts, I agree. Your perspective is much like my own; we must both be working in the trenches. I think the European Model for CE marking of medical devices that is most used, follows what you’re saying, and I do prefer it. Use the Design Control process; develop a design plan to deal with Essential Requirements, and particular risks, wherever they can be squashed, including areas within the ISO 13485 QMS. Third Party testing of product is voluntary. Review of the Design Control and/or Risk Management and Technical File involves a third party assessment (when the QMS audit is performed by the CAB). This approach allows the manufacturer to pick and choose when its best to get a product tested, which as we all know can be a huge obstacle, especially if your entrepreneurial sized and facing a $20,000 or more in lab fees.

Funny thing, since we're talking about IEC 60601-1 Third Edition, this standard is one of the least aligned standards with the EU/GHTF Essential Principles of Safety and Performance. EN standards have an Annex ZZ to show how they line up with the Essential Requirements (annex 1 of 93/42/EEC), and frankly, 60601-1 does a really poor job of it. It only states that meeting the standard meets all of Annex 1 [Essential requirements]", this is laughable. Annex 1 has so many different items that are clearly not addressed in a normal 60601-1 evaluation, its no wonder they decided to forego the embarrassment of creating a checklist matrix, like some Annex ZZ contain. To more clearly distinguish what 60601-1 legitimately addresses in the Essential Requirements; you can look at ISO/TR 16142:2006, which clearly indicates where 60601-1 cannot fill the holes of the Essential Requirements. In my view, this is an irresponsible statement in Annex ZZ of 60601-1. Annex ZZ should appear as a checklist or matrix that allows anyone to clearly identify the section of the standard that can be used for assessing each Essential Requirement. Although 60601-1, by itself, simply can't achieve any significant level of alignment with the Essential Requirements, the CENELEC stamp of approval allows it to be used for meeting ”all the requirements"?

Although you can use this 60601-1 Third Edition, and it really doesn't fill in the blanks very well on your Essential Requirements Checklist, this claim could be defended using an obscure rationale. Since 60601-1 Third Edition heavily uses ISO 14971, which is also a harmonized European Norm EN ISO 14971, the Essential Requirements may quite suitably be checked off using the Risk Management File. So one might argue that IEC 60601-1 is quite suitable for assessing the EU Essential Requirements, but only if you’re weighing in that the ISO 14971 is a key part of 60601-1 Third Edition. You still need to map over the Essential Requirements to considered risks, in the Risk Analysis, to be sure. Even then though, your labeling requirements of the Essential Requirements cannot be fulfilled using either of these standards, and it has to be polished off with an assessment against EN 1041 "Information supplied by the manufacturer". EN 1041 is impeccably aligned with Annex 1 requirements section 13. So with 60601-1, ISO 14971 and EN 1041, perhaps we can finally establish compliance with the “Essential Requirements”. Simply using 60601-1 Third Edition won't do, and this can lead to real problems in other markets.

Keep in mind that the "Essential Requirements" are globally harmonized into GHTF "Essential Principles" GHTF/SG1/N41R9:2005, which is a nearly identical knock-off of the EU Essential Requirements of Annex 1. It’s also being adopted all over the world for regulatory purposes, just as it was designed. Even smaller countries like Egypt are considering transposing GHTF guidance into law. So at the end of the day, we need a standard that best address the Essential Principles of Safety and Performance. There are few if any standards that can be used as a stand alone for that, and despite the claims made in Annex ZZ of the Third Edition, it simply can't be used to address all these GHTF requirements. CENELEC has not authority in Egypt. CEN and CENELEC can only be leaned on at best, for CE marking in Europe.

That's my perspective, from my muddy trench.

Good point - I agree the 3rd edition does not address essential requirements very well, despite the title. I think the reason is conflicting interests: regulation (especially EU) wants a standard that covers everything using subjective methods if necessary, while North American NRTL/SCC really needs a standard covering basic safety only using objective test methods and criteria. The result is something in the middle that does not fit either need very well.

I'm guessing this 3rd edition will cost the world wide industry at least a US$100 million and possibly as much as $500 million once it is played out, accounting not only for testing fees but also internal manufacturer costs. But gains are likely to be very small, as the standard doesn't really get to some of the critical issues in patient safety. The question is, are there better things we could be doing with that $100 million? Absolutely.

That's why resource accountability needs to be brought into standards: no more justification for a broadly applicable requirement on a couple of highly individual hypothetical case studies, without at least considering the cost of broad implementation.