Regulatory Open Forum

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  • 1.  IEC62133:2017 Question

    Posted 20-Dec-2019 01:26
    I am reposting a question asked on a separate RAPS local group as I thought would be of value for the RegEx group too.  My reply is below the original questiton:

    Hi everyone,

    I'm reading conflicting reports about the adoption of the 2nd edition of IEC 62133. Our device contains a Li-ion battery which was certified to IEC 62133:2012. I'm reading that adoption to the 2017 edition is expected by March 2020. On the other hand, I also came across this verbiage from Intertek:
    "existing batteries do not need to be re-certified (to the 2017 edition) unless: a) battery design change occurs or b) end product certification occurs after Mar 14, 2020.

    So, my question is, should I have my secondary Li-ion battery recertified to IEC 62133:2017 for EU market? We already have CE mark with IEC 62133:2012. What about for our 510k, which we hope to file in Q1 2020?

    I've spent hours scouring the Internet for concrete directives but have not been lucky.

    Thank you!

    ------------------------------
    Carol
    ------------------------------

    My reply is below:

    This is not just a regulatory issue but from a national safety standard adoption perspective.  But since I can tell you are talking about medical electrical equipment I have a better answer than this route as this can get convoluted as can be different per country.  The draft of IEC 60601-1, ed. 3.2 which is underway should be published around July - Aug of 2020 (current schedule) is anticipated to allow for either IEC 62133:2012 or IEC 62133-2:2017 (Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems) if the national committees approve the FDIS stage (Final Draft International Standard).  I am on the Maintenance team (IEC SC 62A MT30) that was involved on this edit to the standard.  This is a straight forward edit.  The typical transition period of IEC 60601-1 is 3 years and that text will be inserted into the Foreword of the standard to recommend a 3 year transition period for the adoption of the standard into any national system regulatory or product safety system.



    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------


  • 2.  RE: IEC62133:2017 Question

    Posted 20-Dec-2019 20:45

    I'm working on a similar issue, not involving batteries, that raised some points I would to cover. The issues basically come down to standards and how regulators view them. However, there are issues of risk management and product liability.

    The first issue deals with following an international standard versus a national or regional standard such as in the EU. A national or regional standard will, typically, have an ISO or IEC prefix while the EU standard has the EN prefix. For use in the EU, the expectation is the EN standard not the international standard.

    The original question says, "We already have CE mark with IEC 62133:2012". The CE Mark goes with a directive or a regulation, not a standard. In addition, it states an international standard, not an EU standard. A better statement would be, "We already have a CE mark to xxx directive and used EN 62133:2013". (Note the change in year.) I don't know what directive applies in this case, nor do I know if EN 62133:2013 is harmonized to any directive or regulation.

    I have more than one client who gets confused about the CE mark application based on directives and regulations not standards.

    The original question says, "Our device contains a Li-ion battery which was certified to IEC 62133:2012". Presumably the certification followed the IECEE CB scheme and there is a test report to the current version of the TRF. Problems with these batteries in medical devices are hazards, sequences of events, and hazardous situations in the ISO 14971:2007 or ISO 14971:2019 hazard analysis. With the proper test report, the residual risk is automatically acceptable and the report covers implementation verification and effectiveness verification. However, this depends on having the right report that aligns with the specific hazards.

    Lastly, I want to raise product liability. I've been an expert witness in some cases. Although the expectation seems to be that a test certificate to IEC 62133:2012 is adequate when the standard changes, I would question it. If there were harm (and the law suit), I would look for an analysis of the changes in the standards to ensure they still cover the hazard analysis, i.e., analysis that the prior standard still applies. This is the state of the art question.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------



  • 3.  RE: IEC62133:2017 Question

    Posted 21-Dec-2019 01:33
    I agree with many of Dan's comments but would like to add some of his points:

    Not all national standards are based on IEC and ISO standards (Dan did say typical).  But for the US you may need to also look at UL standards like UL 2054 (Nickel Cell or Lithium/Nickel Battery Packs), UL 1642 (Lithium Cell Batteries), UL 1989 (Standby Batteries).  Typically IEC 6233-2:2017 supersedes most of these but be careful with this.  You need to check with a battery expert on that issue or a test house that really knows that issue well.  There are several.  Then there is also IATA / UN DOT / UN 38.3 T1 - T8. 

    Dan's comment about EU Directives that a standard is tied inspired me to dig on the CENELEC website to see if EN 62133:2013 (equivalent to IEC 62133:2012) and EN 62133-2:2017 (equivalent to IEC 62133:2017) are connected to a Directive and it doesn't look like it from what I can see on the CENELEC website.  I checked the Low Voltage Directive as well and it is not a standard on that list.  I know a lot of manufacturers self declare to that directive and bring up standards that are not on the actual LVD list of Harmonized Standards.  This gets into due diligence.  This is partly what I do for clients many times, is dig into these types of details.

    Dan also brings up a point about Risk Management which is one thing I see is missed many times for Lithium batteries as they have a tendency to explode, are sensitive to temperature (need to consider the environment they are exposed to), etc. Also, I have physically seen a lithium battery grow bigger and bigger and bigger (luckily it didn't explode but easily could have) over several days on my own laptop.  This is quite a hazard and typically not well addressed in many risk management files. The explosion hazards (which can come from many sources of where it is generated from) can be a litigation issue even sometimes if the battery is tested to a standard.  If not tested to the proper standard won't do the right trick or if the battery is tested to the proper standard but the safety circuitry is faulty and the one tested work ok or the mfanufacturer changed the circuitry and didn't go back to the test lab to recertify the product.  The list can keep going so I will stop for now.

    Note, a slight clarification on Dan's point about an IECEE CB Scheme test report to IEC 62133:2012 or IEC 62133-2:2017 TRF's (Test Report Forms) if a Lithium battery was tested to these standards (62133) would not consider ISO 14971 of any flavor as that is not a requirement of either of these standards.  IEC 60601-1 states in the component clause 4.8 if a component is used within it's ratings no risk management is required for that component to meet IEC or EN 60601-1, ed. 3.1.

    A separate note, becasue brooched the subject it is anticipated that ISO 14971:2019 will be a normative reference in IEC 60601-1, ed. 3.2 when published and all the collateral standards (e.g. IEC 60601-1-XX) that will be published at the same time.  That is the current plan.

    I think that is enough for now.

    Happy holidays to one and all and to a propserous and SAFE New Year,


    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------



  • 4.  RE: IEC62133:2017 Question

    Posted 21-Dec-2019 08:58
    Interesting post.   I have a filing yet this month with  battery  certified to IEC 62133:2012 through CB report.   FDA's Consensus standards database says this will not accept this version after this month, but at least it will be submitted.

    Based on Leonard and Dan's comments, they are wondering how hard or how to push back if asked for the 2017 version 62133-2 : 2017 if asked during review.



    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------



  • 5.  RE: IEC62133:2017 Question

    Posted 21-Dec-2019 11:16
    My response is from the risk management and product liability perspective.

    I infer you have ISO 14971:2007 implemented and use ISO/TR 24971:2013.

    The scenario is that someone is hurt and alleges a device problem in general and a battery problem in particular. The plaintiff's attorney starts the discovery process and hires an expert witness in risk management. The discovery request asks for the risk management file.

    The expert witness will look for hazards, sequences of events, and hazardous situations related to the battery. Because these problems are well known the expert witness would expect to see sources from the literature.

    The manufacturer will probably follow ISO/TR 24971:2013, clause 2.2 Use of international product safety standards in risk management. In particular 2.2.a applies.

    The conclusion is that IEC 62133:2012 covers the hazards and the test report provides the evidence of conformity, so the residual risk in each case is acceptable.

    The expert witness would then look at ISO 14971:2007 clause 9.b and the considerations of new or revised standards. This leads to IEC 62133-2:2017 and its associated test report. The expert witness would expect one of two things.
    • An evaluation of the new standard for possible relevance to safety with a conclusion that nothing in the new standard affects the prior analysis
    • Implementation of the new standard and a conclusion that, based on the new test report, the residual risk is acceptable.

     Moreover, a check of the dates suggests that FDA established a transition period and manufacturer just made it. If there is any documentation that says the submission was rushed to meet the deadline, that would also show up in discovery.

    It looks to me that the plaintiff is well on the way winning the case.

    From the submission point of view, I would not push back, because I would plan to get the certificate to the new standard. This makes any reviewer questions a non-issue.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------



  • 6.  RE: IEC62133:2017 Question

    Posted 22-Dec-2019 01:10
    Well, you paint a worst case scenario Dan..  if the old standard is so bad,  why would it still be allowed under IEC 60601-1 ed 3.2. Seriously, the risk of this device ever causing a serious injury is remote.

    No worries, client has testing going, just not in time for this cutoff.

    Merry Christmas to all.



    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------



  • 7.  RE: IEC62133:2017 Question

    Posted 22-Dec-2019 23:05
    And this is how risk management works, no?  You consider probability and severity across all risks and then allocate your resources accordingly.  In the end, it's a business decision.

    If I wanted to pursue this further, I think I'd be inclined to take a different approach.  Instead of weighing old standard versus new standard, I'd take a look at the old versus new testing requirements and how they would apply to my device. Then I'd take a look at my risk assessment and see what impact the new testing requirements might have on risks related to electrical safety.  If the risk is remote to begin with, the impact could be negligible.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 8.  RE: IEC62133:2017 Question

    Posted 23-Dec-2019 07:44
    Hi Julie

    I agree with that approach, but some agencies don't because they have a check the box mentality or their government's penalty for failing to do an in-depth review is too high (think China).

    Hope you all have a great Christmas and New Year!

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------



  • 9.  RE: IEC62133:2017 Question

    Posted 23-Dec-2019 10:18
    Yes, I was thinking for the purposes of risk management, not for regulatory purposes.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------