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Biological Evaluation acc. to ISO 10993-1

Discussion in 'EU Medical Device Regulations' started by Achaos, Aug 29, 2015.

  1. Achaos

    Achaos Member

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    Hello,

    we are planning a biological evaluation for a single use component. The component will apply to the mucousal membran for a short time (<10 minutes). We are planning a chemical characterization according to ISO 10993-12 / -18 and 17. Additional we are planning a cytotoxicity test according to ISO 10993-5.
    In accordance to ISO 10093-1 an irritation and sensibilisation test should be also applied. We would like to avoid the animal tests. We analyzed the raw materials and we don't expect leachable substances above threshold limits. What would be an acceptable justification to avoid the animal tests?
    Thank you for your assistance.
     
  2. Ronen E

    Ronen E Well-Known Member

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    What is pushing you towards ISO 10993 compliance? A regulatory requirement? A client request?

    Normally ISO 10993 requirements apply to finished devices, not to components on their own.
     
  3. Achaos

    Achaos Member

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    The single use component is part of a medical device (accessory). We are the manufacturer of this medical device and the belonging single use component. We are planning a clinical investigation for the medical device and the accessories. The biological evaluation is a requirement to propose a clinical investigation to the competent authorities. The single use component will not get an own registration/approval (that's why I'm using the therm component and not single use device).
     
  4. Ronen E

    Ronen E Well-Known Member

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    Why is this component being biologically evaluated on its own, and not as part of evaluating the whole device/system?
     
  5. Achaos

    Achaos Member

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    It`s the applied part of the medical device. No other part is in contact with the patient.
     
  6. Ronen E

    Ronen E Well-Known Member

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    Thanks for clarifying.

    I assume you refer to the obligation under the MDD Annex VIII to comply with essential Requirement 7.1.

    Demonstration of compliance with the ERs doesn't mandate following a harmonized standard (e.g. ISO 10993-1). You have the right to use other methods, but you have to justify how they meet the ER. ISO 10993-1 is considered state of the art though, so you have to have a robust justification if you are deviating from its prescribed tests.

    If you could get a formal, written opinion from an experiences toxicologist, employed by an accredited test lab (e.g. NAMSA etc.), justifying how your proposed test outline guarantees the biological safety of the applied part (under the intended use conditions), it might suffice.

    I have no affiliation whatsoever with NAMSA.

    Cheers,
    Ronen.
     
  7. Achaos

    Achaos Member

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    Hi Ronen,

    thanks for the statement. What should I ask the toxicologist? We don`t have leachable substances to evaluate. In my opinion the ISO 10993-1 matrix to choose the applicable test is inapprobriate for applied parts with direct contact to healthy skin or mucosal membran. The clothing industry (clothes with contact to skin) must not observe ISO 10993-1 standards, or?
    Could we avoid animal tests for applied parts with contact to healthy skin or membran if we perform a chemical characterization acc. to ISO 10993-18 and the chemical chemical characterization shows no leachable substances (with approbriate solvents (e.g. water or balanced salt solution))?
     
  8. Ronen E

    Ronen E Well-Known Member

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    You gave the answer:


    Standards are supposed to represent a wide consensus. You are entitled to your own opinions, but if they deviate from that consensus they are relevant only if you can adequately justify them (i.e. with the support of an accredited lab's toxicologist). I'm not familiar with clothing regulations, but I guess that clothing materials have their own safety standards and that the potential reaction with human skin is taken into account.

    Cheers,
    Ronen.
     
  9. jojo63

    jojo63 Member

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    Hi all,

    I search information to address the same problem.

    We manufacture a vaginal applicator. I identify two identical products manufactured with the same type of raw material (LDPE).

    Is it possible to write a report according to ISO 10993-1 with these elements? If yes, how?

    Thank you for help.

    Jojo.
     
  10. Ronen E

    Ronen E Well-Known Member

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    Hi Jojo,

    With this level of detail ("LDPE") it's highly unlikely that you will get any concession. "LDPE" is too generic, and even if you used the exact same grade, your process might be different. In the main regulatory schemes biocompatibility is evaluated for the finished product.

    What you might opt for is "equivalence testing" (or equivalence justification). You will need the support of ISO 10993 accredited test lab for that (I'm not affiliated with any such lab).

    Cheers,
    Ronen.
     
    Somashekar likes this.
  11. Somashekar

    Somashekar Moderator Staff Member

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    Bio-compatibility tests cannot be grandfathered. They are always to your product, no matter how many similar products with same material are tested bio-compatible. Who is the user of your bio-compatibility test report ? Regulatory Authorities ?
    Can you ask them also what stand they take. This will meet your core purpose.
     
  12. jojo63

    jojo63 Member

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    The first user is the notified body. Sales volumes of our device are low. Our goal is to demonstrate the biocompatibility as simply (but according regulatory requirements). If we can avoid animal tests is even better.
     

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