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    ISO 10993-9:2019

    ISO 10993-9:2019

    ISO-10993-9:2019
    ISO 10993-9:2019

    ISO 10993-9:2019 Biological evaluation of medical devices —

    Part 9: Framework for identification and quantification of potential degradation products

    The identification and quantification of potential degradation products is a key requirement of the biological evaluation of medical devices. The aim of this article is to provide an overview of the requirements of ISO 10993-9:2019, which sets out a framework for the identification and quantification of potential degradation products.

    What is ISO 10993-9:2019 ?

    ISO 10993-9:2019 provides a framework for the identification and quantification of potential degradation products that may be formed during the storage or use of medical devices.

    The aim of this standard is to provide a systematic approach for the identification of potential degradation products, and to provide guidance on how to quantify these degradation products.

    This standard is applicable to all medical devices that are subject to storage or use under conditions that may lead to degradation.

    What are the requirements of ISO 10993-9:2019?

    The requirements of ISO 10993-9:2019 are intended to provide a framework for the identification and quantification of potential degradation products from medical devices.

    The standard provides guidance on how to select appropriate analytical methods for the detection and quantification of potential degradation products.

    It also includes information on how to interpret the results of the analysis and how to use the data to assess the potential risk to patients.

    What are the benefits of ISO 10993-9:2019 ?

    ISO 10993-9:2019 provides a framework for the identification and quantification of potential degradation products that may be formed during the use of medical devices.

    The benefits of this standard include:

    1. Improved safety of medical devices – by identifying and quantifying potential degradation products, manufacturers can ensure that their devices are safe for use.
    2. Enhanced product quality – by understanding the potential for degradation, manufacturers can take steps to prevent or mitigate it, resulting in improved product quality.
    3. Reduced costs – by preventing or mitigating degradation, manufacturers can avoid the cost of replacement or repairs.
    4. Increased customer satisfaction – by providing safe and high-quality products, customers will be more satisfied with their purchase.

    If you need more support with ISO 10993-9:2019, please contact us at +91-8595603096 or support@pacificcert.com