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  • 1.  NRTL marking battery powered devices

    This message was posted by a user wishing to remain anonymous
    Posted 03-Aug-2018 11:10
    This message was posted by a user wishing to remain anonymous

    Do battery powered devices require NRTL marking for sale into US and/or Canada?


    regards
    Mike


  • 2.  RE: NRTL marking battery powered devices

    Posted 06-Aug-2018 09:49
    ​Any medical device which falls under the scope of 60601-1 requires a NRTL mark in the U.S. and Canada.  While most of the mains powered requirements are N/A, all the requirements around color codes, instructions for use, risk management, etc... still apply.

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    Al Van Houdt, RAC
    Sr. Mgr. Regulatory Affairs & Compliance
    Spacelabs Healthcare Inc.
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    Original Message


  • 3.  RE: NRTL marking battery powered devices

    Posted 07-Aug-2018 18:07
    Also, there are specific battery requirements (how placed, markings, etc.) and many battery types have additional safety concerns (i.e. Lithium rechargeable batteries).

    ------------------------------
    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
    ------------------------------

    Original Message


  • 4.  RE: NRTL marking battery powered devices

    This message was posted by a user wishing to remain anonymous
    Posted 09-Aug-2018 08:48
    This message was posted by a user wishing to remain anonymous

    Thank you so much for the responses .

    Can anyone tell me where is it the requirements for NRTL is cited other than OSHA which is related to product used in the workplace.
    I know of medical electrical devices that have been cleared by FDA without NRTL mark and FDA does not required the NRTL mark as part of a submission.
    I have heard it said that it is NRTL is required for products used in the workplace and for products that connected to the mains supply.
    While I can requirement #1 in OSHA documentation I cannot find anything for #2.
    The laboratories that provide NRTL marking will recommend it for all electrical products. 
    regards
    Mike

    ​​
    Original Message


  • 5.  RE: NRTL marking battery powered devices

    Posted 10-Aug-2018 10:19
    ​Don't confuse FDA requirements with OSHA requirements.  They have nothing in common.  The same is true in Canada.  You can get a Health Canada license, but they do not ask for a NRTL mark.  They just want to know if you meet applicable standards.  For OSHA, the applicable standard for medical devices is AAMI ES60601-1:2005/(R)2012.  For devices in the workplace, the only way to easily prove that is with the NRTL mark.

    ------------------------------
    Al Van Houdt RAC
    Sr. Mgr. Regulatory Affairs & Compliance
    Snoqualmie WA
    United States
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    Original Message


  • 6.  RE: NRTL marking battery powered devices

    Posted 12-Aug-2018 02:44
    Yes OSHA & FDA are two separate entities but I actually just dealt with this question and I have a contact at OSHA in the NRTL program so his answer with some re-formatting is below which should answer your question.  So, the answer is even battery-operated devices that are medical devices used in a work environment would fall under this requirement, which many manufacturers don't realize applies to them.  

    All electrical equipment (including medical devices) comes under Subpart S. There is a reference in Subpart S for "utilization equipment".  Utilization equipment is defined in 1910.399 with a very broad definition that incorporates all electrical equipment.  It is so broad that battery operated devices also fall under this category.

    The requirement for NRTL approval comes from Subpart S of the OSH Act (which begins at 29 CFR 1910.301) https://www.gpo.gov/fdsys/pkg/CFR-2017-title29-vol5/pdf/CFR-2017-title29-vol5-sec1910-301.pdf 
    Subpart S applies to all electrical equipment used in the workplace

    1910.303 establishes the approval requirements: "  The conductors and equipment required or permitted by this subpart shall be acceptable only if approved, as defined in §1910.399" https://www.gpo.gov/fdsys/pkg/CFR-2017-title29-vol5/pdf/CFR-2017-title29-vol5-sec1910-303.pdfhttps://www.gpo.gov/fdsys/pkg/CFR-2017-title29-vol5/pdf/CFR-2017-title29-vol5-sec1910-303.pdf 1910.399 provides the definitions for "Acceptable" and "Approved"  https://www.gpo.gov/fdsys/pkg/CFR-2017-title29-vol5/pdf/CFR-2017-title29-vol5-sec1910-399.pdf  The definition for "Acceptable" is where the NRTL approval requirements are mentioned.



    Hope this helps,


    ------------------------------
    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
    ------------------------------

    Original Message


  • 7.  RE: NRTL marking battery powered devices

    Posted 13-Aug-2018 03:26
    Hi Leonard,

    Would you it be correct to say then that NRTL does not apply to medical devices used in the home environment (as opposed to workplace environment) regardless of whether the device is battery or mains powered?

    regards
    Mike



    ------------------------------
    Mike Kilkelly
    Quality Manager
    Galway
    Ireland
    ------------------------------

    Original Message


  • 8.  RE: NRTL marking battery powered devices

    Posted 14-Aug-2018 02:17
    I'm replying to the whole group not just Mike,

    If there is any <g class="gr_ gr_76 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling" id="76" data-gr-id="76">worker</g> that deals with the home use device than you still need NRTL.  The home can be a <g class="gr_ gr_77 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling" id="77" data-gr-id="77">workplace</g> so you need to consider who is using the device. So, if a nurse or a sale person sets-up the device or even a caregiver that works for a company sets-up or uses the device than it would still need NRTL mark.


    ------------------------------
    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
    ------------------------------

    Original Message


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