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    ISO 10993

    ISO 10993

    ISO 10993

    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements

    Every year, countless medical devices are introduced to the market. In order for these products to be safe for human use, they must first go through a series of tests. One of the most important steps in this process is the biological evaluation, which assesses the potential risks posed by the device to both patients and healthcare workers. The international standard for biological evaluation is ISO 10993-2:2006, and in this article we’ll take a closer look at what it entails.

    What is ISO 10993-2:2006 ?

    ISO 10993-2:2006 defines the principles and methods to be used in the animal welfare requirements for the biological evaluation of medical devices.

    The standard applies to all medical devices that come into contact with living animals, including invertebrates, as part of their intended use.

    It is important to note that this standard does not apply to products that are solely for veterinary use.

    The standard covers the following topics:

    • The selection of animals for use in testing
    • The housing and care of animals during testing
    • The humane endpoints for each test
    • The documentation and reporting of results

    The aim of this standard is to ensure that the welfare of animals is considered during the testing of medical devices. This includes ensuring that the animals are treated humanely and with respect throughout the testing process.

    What are the requirements of ISO 10993-2:2006

    The general requirements apply to all medical devices, regardless of their intended use. These requirements cover the need to assess the potential risks to animal welfare during the design and manufacture of medical devices.

    The specific requirements are specific to certain types of medical devices. These requirements cover the need to assess the potential risks to animal welfare during the use of medical devices.

    There are four Annexes in ISO 10993-2:2006 which give guidance on how to comply with the general and specific requirements. Annex A (Informative) provides an overview of animal welfare legislation and standards. Annex B (Informative) gives guidance on how to select appropriate animals for testing. Annex C (Informative) provides guidance on how to carrying out tests on animals. Annex D (Informative) provides guidance on how to assess the results of tests on animals.

    What are the benefits of ISO 10993-2:2006

    The benefits of ISO 10993-2:2006 are many and varied. The standard provides guidance on the design of animal welfare requirements for medical devices, which can help to improve the welfare of animals used in research and testing.

    In addition, the standard can also help to ensure that medical devices are safe for use in humans. By adhering to the guidelines set out in ISO 10993-2:2006, manufacturers can help to ensure that their products meet the highest safety standards.

    Ultimately, the goal of ISO 10993-2:2006 is to improve the welfare of animals used in research and testing, while also helping to ensure the safety of medical devices. By following the guidelines set out in this standard, manufacturers can help to achieve both of these objectives.

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