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  • 1.  Clarity on ISO 10993 for medical devices

    Posted 16-Aug-2023 02:27

    Hi all,

    Please guide me on below.

    We are manufacturing Metered Dose Inhaler medical device. Do we have to prove the biocompatibility of all the parts of the device or testing the biocompatibility of the parts that comes in contact with the human body alone would suffice for product registration?

    Also, do we have to test the biocompatibility of the parts of the device that comes in the breathing air pathway of MDI?



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    Anoosha Bhat
    Bengaluru
    India
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  • 2.  RE: Clarity on ISO 10993 for medical devices

    Posted 16-Aug-2023 09:11

    Hi Anoosha

    Yes, the parts of the device in the breathing air pathway are what the standard refers to as "indirect" contact with the human body. (The parts that touch the hands, face, etc have "direct" contact.)



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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Clarity on ISO 10993 for medical devices

    Posted 16-Aug-2023 14:35
    A biological evaluation must be done to assess the biocompatibility related risks associated with the use of the medical device with direct and/or indirect contact with human tissue or body.

    This assessments should help determine the potential for an unacceptable adverse biological response, unless you can justify that the materials have a long history of safe use in medical devices that come in contact with human skin, body or tissue. Since this is an inhaler you probably need sufficient rationale to justify not performing biocompatibility tests. So the question is- Is the inhaler considered an intact skin contacting medical device?

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    Noreen Svensson


    1187 EE Amstelveen
    Netherlands
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    Original Message


  • 4.  RE: Clarity on ISO 10993 for medical devices

    Posted 17-Aug-2023 10:20
    Edited by Lee Leichter 17-Aug-2023 10:21

    Dear Anoosha,

    Specific biocompatibility requirements of the air path for medical devices are covered by another set of standards.  These would also be applicable to MDIs. 

    • ISO 18562-1 Biocompatibility of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process;
    • ISO 18562-2, Biocompatibility of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter;
    • ISO 18562-3, Biocompatibility of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic compounds (VOCs);
    • ISO 18562-4, Biocompatibility of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate,

    These cover all the aspects specific to gas or air pathways. 

    I hope this is helpful.



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    Lee Leichter RAC
    President
    Fort Denaud FL
    United States
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    Original Message


  • 5.  RE: Clarity on ISO 10993 for medical devices

    Posted 17-Aug-2023 03:26

    Hi Anoosha,

    please be aware that for gas pathways ISO 18562 series (Biocompatibility evaluation of breathing gas pathways in healthcare applications) needs to be applied additionally to ISO 10993.

    Best, Dirk



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    Dirk Steinhoff PhD
    Senior Consultant
    Zug
    Switzerland
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    Original Message


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