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  • 1.  Conflicting Infusion Set/Pump Requirements

    Posted 10-Sep-2013 09:43
    Dear RAPS Community,

    Is anyone able to help provide some clarification/assistance regarding what appear to be conflicting requirements for infusion set/pump performance and labeling requirements as described in ISO 8536-8 and IEC 60601-2-24?

    Specifically, ISO 8536-8, under 6.14 describes that storage volume is to be determined in accordance with IEC 60601-2-24 and declared in labeling in accordance with ISO 8536-8 10.1(h). However IEC 60601-2-24 describes that the testing is to be performed at 20C +/- 2C / 65%RH +/- 5%RH, while ISO 8536-8 10.1(h) describes that the storage volume should be stated at 40C.

    Any assistance on this would be greatly appreciated.

    Best regards,
    Michael

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    Michael Dun
    RA & Technical Consultant
    Ambiente & Qualidade
    Campinas
    Brazil
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  • 2.  RE:Conflicting Infusion Set/Pump Requirements

    Posted 11-Sep-2013 11:06
    While I can see the technical problem of resolving these two discordant standards, the actual difference with regard to a reservoir capacity should be trivial (<0.5% volume difference of water between 20° and 40° C). This is a reservoir and you want to know and label its capacity properly; this is not a volumetric flask trying to meet some high standard of precision. If the reservoir was expected to hold 1000 ±10 mL of water, it would not make any significant difference if this were measured at 20° or 40°, as you would still be well within the ±10 mL range. It would be even less different if the reservoir were for saline, as that coefficient of expansion is smaller. My point being, either method will get you what you need, just do not set an unnecessarily tight design tolerance for the capacity of the resevoir. Better to attend to the delivery rates of the pumping system, where precision is more important. If your pump was designed to warm the reservoir closer to body temperature prior to infusion, then it might make sense to use the higher temperature as the reference. But why the standards seem so different, I cannot say.


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    Jan Peterson RAC
    Rockville MD
    United States
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  • 3.  RE:Conflicting Infusion Set/Pump Requirements

    Posted 12-Sep-2013 08:21
    Hi Jan,

    Thank you for your response on my posting. Your feedback is logical and aligns with the risk-based strategy that I had planned on adopting in this scenario. The intended use and design of the pump and infusion sets should assist me in determining the impact that temperature will have upon storage precision limits and therefore which temperature to use during testing. As to the specific difference in the standards I've also reached out to ISO for clarification and should hopefully receive a response from them soon.

    Best regards,
    Michael

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    Michael Dun
    Campinas
    Brazil
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    Original Message


  • 4.  RE:Conflicting Infusion Set/Pump Requirements

    Posted 12-Sep-2013 09:42
    Michael,

    It seems you are in Brazil. I suppose you are following Br. Official Gazette, dated 2/1/2010 for the type of infusion pump you are working on.  There are some differences as for the use of the standards (e.g., gravity drip infusion equipment/pump) between UK, Brazil, and US.  

    In view of ISO 8536-8 and IEC 60601-2-24, my understanding has been that:

    As for testing temp., it should be done at 20C as the intended use reflects.
    As for the infusion sets per ISO 8536-8, 40C should be in your tech spec.

    Thanks!
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    President and Principal
    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message


  • 5.  RE:Conflicting Infusion Set/Pump Requirements

    Posted 12-Sep-2013 16:27
    Dear Michael & Members,

    There is indeed a mistake providing IEC 60601-2-24 as the reference for the test method and it seems it will be taken into account with the current running revision of the ISO 8536-8. Neither standard provides acceptance criteria for the storage volume, therefore there isn't a maximum storage volume defined by the standard.

    The manufacturer itself has to determine and document the appropiate value for the maximum storage volume. 

    Based on the above, the ISO 8536-8 may be satisfied by verifying that a storage volume has been stated on the product label per section 10.1 h


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    I hope this helps.

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    PAOLA GONZALEZ
    HOSPIRA
    Mexico
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