Regulatory Open Forum

 View Only
  • 1.  ISO 10993-1:2020 - classification of contact

    This message was posted by a user wishing to remain anonymous
    Posted 14-Jun-2022 10:33
    This message was posted by a user wishing to remain anonymous

    Hi All

    What would be your take on classifying a device which channels gas (air/oxygen/CO2) for delivery into oxygenator during CPB, in terms of contact as per ISO 10993-1:2020? The gas channelled by the device will eventually be delivered to blood within CPB. The oxygenator is not part of the device in question.

    ISO 10993-1:2020 has a very specific definition of blood path, indirect contact:


       Medical devices or components that do not necessarily directly contact the blood path directly but serve as conduits to deliver fluids into
       the vascular system.

     EXAMPLES    Solution administration sets, extension sets, transfer sets and blood administration sets.

    But the standard also refers to ISO 18562 for gas pathway devices with only indirect contact:

       For gas pathway device components with only indirect contact, device specific standards should be used to determine the relevant type       of biocompatibility evaluations [see ISO 18562 (all parts)].

    This standard (ISO 18562), however, is not applicable as its scope is for devices, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. Our device does not supply gas via respiratory tract.

    When reviewed against the 2009 version of the ISO 10993-1 standard, our Notified Body agreed that biocompatibility testing does not need to be performed - would you say that the 2020 version of the standard changes that?

    Many thanks in advance


  • 2.  RE: ISO 10993-1:2020 - classification of contact

    Posted 02-Jul-2022 02:44
    Hi,

    You can look for classification of medical device on FDA website and check for regulatory pathway applicable for predicate device which would help to take decision on requirement for bio compatibility assessment.
    Thanks and Regards.

    ------------------------------
    [Monaz] [Mysorewala] [M.Sc., DABT, ERT]
    [Manager]
    [SPARCL]
    [Vadodara] [Gujarat]
    [India][monazmysorewala@outlook.com][+91 9979118085]
    ------------------------------



  • 3.  RE: ISO 10993-1:2020 - classification of contact

    Posted 02-Jul-2022 15:16
    Hi Anon

    It's hard to say if a NB today would even agree with the same rationale they agreed with some years ago.

    The 2020 edition of 10993-1 did introduce a few endpoints that were not part of the 2009 edition. Check Annex A and see if your rationale still seems to make sense.

    I can see the challenge where this device falls between standards, with gases typically delivered to the respiratory system and liquids more typically delivered to the blood. But the general principles of 10993-1 should still apply.

    Do you have a characterization of substances that could pass from the gas channel into the gas and from there into the blood?

    I'd imagine toxicity and haemolysis and suchlike could be applicable in some circumstances, since theoretically you could select a really inappropriate material. On the other hand, if you can show the risk is low, then there may still be no testing necessary.

    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------