d

WE ARE Pacific Cert

Let’s Work Together

W/116/B-28, Jawalapuri, Paschim Vihar, New Delhi-110087

Contact Us

    Image Alt

    ISO 10993-5:2009

    ISO 10993-5:2009

    ISO-10993-5:2009
    ISO 10993-5:2009

    ISO 10993-5:2009 Biological evaluation of medical devices —

    Part 5: Tests for in vitro cytotoxicity

    There are many tests that need to be carried out in order to ensure the safety of a medical device. One of these tests is the in vitro cytotoxicity test, which assesses the potential toxicity of a device when it comes into contact with human cells. This article will explain what the in vitro cytotoxicity test is, why it’s important, and how it’s carried out.

    What is ISO 10993-5:2009?

    ISO 10993-5:2009 is an international standard that provides guidance on the evaluation of the potential cytotoxic effects of medical devices.

    The standard covers a range of in vitro tests that can be used to assess the potential cytotoxic effects of medical devices. These tests can be used to assess the potential for cell death, DNA damage, and other adverse effects.

    The tests described in ISO 10993-5:2009 are not intended to be used as a sole basis for decision-making about the safety of a medical device. Instead, they should be considered as part of a larger body of evidence that includes data from animal studies, clinical studies, and other sources.

    ISO 10993-5:2009 is one of a series of standards on biological evaluation of medical devices (ISO 10993).

    What are the requirements of ISO 10993-5:2009?

    The requirements of ISO 10993-5:2009 are as follows:

    1. The test shall be conducted using at least two cell lines, of which one is mammalian and the other is not.
    2. The cells shall be exposed to the material for at least 24 hours.
    3. The test shall be conducted in triplicate.
    4. A positive control shall be included in the test.
    5. The cytotoxicity of the material shall be determined by measuring the number of cells that are dead or dying.
    6. The results of the test shall be expressed as a percentage of dead or dying cells relative to the control group.
    7. The material shall be considered to be cytotoxic if the percentage of dead or dying cells is greater than 50%.

    What are the benefits of ISO 10993-5:2009?

    The benefits of ISO 10993-5:2009 are many and varied. This standard provides guidance on the tests that should be carried out to assess the in vitro cytotoxicity of medical devices. These tests help to ensure the safety of medical devices, by ensuring that they are not toxic to human cells.

    In vitro cytotoxicity tests are important for a number of reasons. Firstly, they help to assess the potential toxicity of a medical device. Secondly, they can help to identify any potential side effects that a device may have. And finally, they can help to improve the design of medical devices, by helping to identify any areas where further safety testing is required.

    If you need more support with ISO 10993-5:2009, please contact us at +91-8595603096 or support@pacificcert.com