ISO/TS 10993-20:2006 Biological evaluation of medical devices —
Part 20: Principles and methods for immunotoxicology testing of medical devices
In order to ensure the safety of medical devices, it is necessary to conduct comprehensive biological evaluations. ISO/TS 10993-20:2006 provides guidance on the principles and methods for immunotoxicology testing of medical devices. This standard is applicable to all types of medical device, including those made from polymers, metals, ceramics and glass.
What is ISO 10993-20:2006?
ISO 10993-20:2006 is an international standard that provides principles and methods for immunotoxicology testing of medical devices. The standard is intended to be used by manufacturers, regulators, and other stakeholders in the medical device industry.
The standard covers six main areas:
- Principles of immunotoxicology
- In vitro methods
- In vivo methods
- Data interpretation and reporting
- Risk management
Each of these sections provides guidance on how to carry out immunotoxicology testing in a way that is safe and effective. The standard also includes a list of references for further reading.
ISO 10993-20:2006 is an important tool for anyone involved in the design, manufacture, or regulation of medical devices. By following the guidance in this standard, you can help to ensure that medical devices are safe and effective for patients and users.
What are the requirements of ISO/TS 10993-20:2006?
The standard ISO/TS 10993-20:2006 provides requirements for the biological evaluation of medical devices with respect to their potential immunotoxicity. The standard applies to all medical devices, including in vitro diagnostic (IVD) medical devices.
The standard includes requirements for the selection of animals for testing, as well as the methods to be used for immunotoxicity testing. The methods described in the standard are:
In vivo tests:
- skin sensitization test
- local lymph node assay
- systemic lymph node assay
- direct lymphocyte cytotoxicity test
- mixed lymphocyte reaction test
- recall proliferation assay
- delayed type hypersensitivity test
- active anaphylaxis assay
- passive anaphylaxis assay
In vitro tests:
- cell proliferation assay – cytokine release assay – natural killer cell cytotoxicity assay – T cell receptor stimulation assay
What are the benefits of ISO 10993-20:2006?
There are many benefits of ISO 10993-20:2006, including:
- It provides guidance on how to conduct immunotoxicology testing of medical devices.
- It helps to ensure that medical devices are safe for patients with allergies or sensitivities.
- It can help manufacturers to improve the safety of their products.
- It can help to reduce the risk of adverse reactions in patients who use medical devices.
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