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    ISO 10993-3:2014

    ISO 10993-3:2014

    ISO-10993
    ISO 10993

    ISO 10993-3:2014 Biological evaluation of medical devices —

    Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

    There are many potential risks associated with medical devices, including biological risks. In order to ensure the safety of medical devices, the International Organization for Standardization (ISO) has published a series of standards on the topic, including ISO 10993-3:2014.

    This standard provides guidance on the design and conduct of tests for genotoxicity, carcinogenicity and reproductive toxicity. It is intended to be used by manufacturers and regulators when evaluating the safety of medical devices.

    What is ISO 10993-3:2014

    ISO 10993-3:2014 is the international standard for biological evaluation of medical devices. It provides guidance on how to select and carry out tests for genotoxicity, carcinogenicity and reproductive toxicity.

    The standard is divided into three parts:

    Part 1: Tests for genotoxicity

    Part 2: Tests for carcinogenicity

    Part 3: Tests for reproductive toxicity

    Each part of the standard contains specific guidance on how to carry out the tests. For example, Part 1 provides guidance on how to test for genetic damage caused by a medical device. Part 2 provides guidance on how to test for cancer-causing potential. And Part 3 provides guidance on how to test for effects on fertility and development.

    The purpose of ISO 10993-3:2014 is to help ensure that medical devices are safe for use. By following the guidance in this standard, manufacturers can help ensure that their devices do not pose a risk to human health.

    What are the requirements of ISO 10993-3:2014

    The requirements of ISO 10993-3:2014 are as follows:

    1. Tests for genotoxicity shall be conducted to assess the potential of the medical device to cause genetic damage.
    2. Tests for carcinogenicity shall be conducted to assess the potential of the medical device to cause cancer.
    3. Tests for reproductive toxicity shall be conducted to assess the potential of the medical device to cause adverse effects on reproduction.

    What are the benefits of ISO 10993-3:2014

    There are many benefits to using ISO 10993-3:2014 when evaluating the safety of medical devices. This standard provides guidance on how to test for genotoxicity, carcinogenicity and reproductive toxicity.

    ISO 10993-3:2014 can help to ensure that medical devices are safe for use by patients and healthcare professionals. This standard can also help to improve the quality of data that is collected during safety testing.

    ISO 10993-3:2014 can help to reduce the risk of adverse events associated with medical devices. This standard can also help to improve patient safety and satisfaction with medical devices.