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    ISO 10993-15

    ISO 10993-15

    ISO-10993-15
    ISO 10993-15

    ISO 10993-15:2019 Biological evaluation of medical devices —

    Part 15: Identification and quantification of degradation products from metals and alloys

    With the increasing use of metals and alloys in medical devices, it is important to ensure that these materials are safe for use in the human body. ISO 10993-15:2019 provides guidance on the identification and quantification of degradation products from metals and alloys. This standard will be of interest to those involved in the design, manufacture, and testing of medical devices made with metals or alloys.

    What is ISO 10993-15:2019?

    ISO 10993-15:2019 is the international standard that specifies the requirements and procedures for the identification and quantification of degradation products from metals and alloys used in medical devices.

    The standard covers the following aspects:

    • Identification of degradation products
    • Quantification of degradation products
    • Characterization of degradation products

    The standard is applicable to all medical devices that contain metals or alloys. This includes, but is not limited to, implants, stents, pacemakers, and other devices that come into contact with body tissues or fluids.

    The objective of this standard is to ensure that degradation products from metals and alloys used in medical devices are identified and quantified in a consistent and reliable manner. This will help to ensure the safety and efficacy of medical devices.

    What are the requirements of ISO 10993-15:2019?

    ISO 10993-15:2019 specifies requirements for the identification and quantification of degradation products from metals and alloys that may be released from medical devices during their intended use. It is applicable to all metals and alloys that are used in medical devices, including those that are coated or plated.

    What are the benefits of ISO 10993-15:2019?

    The benefits of ISO 10993-15:2019 are many and varied. This standard provides guidance on the identification and quantification of degradation products from metals and alloys used in medical devices.

    By adhering to this standard, manufacturers can be sure that their devices will be safe for use in the human body. This is because the standard requires the identification of all potential degradation products, as well as their quantification.

    In addition, this standard also provides guidance on how to control these degradation products. This is important in order to ensure that they do not pose a risk to human health.

    Overall, ISO 10993-15:2019 provides a comprehensive framework for the safety evaluation of medical devices containing metals and alloys. By following this standard, manufacturers can be confident that their devices will be safe for use in the human body.

    If you need more support with ISO 10993-15, please contact us at +91-8595603096 or support@pacificcert.com