ISO 10993-6:2016 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
In order to ensure the safety of medical devices, it is important to consider how they will interact with the human body. The ISO 10993-6:2016 standard provides guidance on how to evaluate the potential for local effects after implantation of a medical device.
What is ISO 10993-6:2016
ISO 10993-6:2016 is the international standard for the biological evaluation of medical devices. The standard provides guidance on the tests that should be carried out to assess the local effects of medical devices after implantation.
The tests described in ISO 10993-6:2016 are designed to assess the potential for local irritation, inflammation, and tissue reaction. These tests can be used to evaluate both implanted and non-implanted medical devices.
ISO 10993-6:2016 is divided into two parts. Part 1 provides general guidance on the principles of biological evaluation, while Part 2 contains specific guidance on the tests that should be carried out.
Part 2 of ISO 10993-6:2016 contains guidance on the following tests:
- Cytotoxicity testing
- Sensitization testing
- Intracutaneous reactivity testing
- Implantation testing
- Irritation and delayed hypersensitivity testing
What are the requirements of ISO 10993-6:2016
The requirements of ISO 10993-6:2016 are as follows:
- The biological evaluation of medical devices shall be performed in order to determine their potential risks to human health.
- The biological evaluation shall take into account the intended use of the medical device, as well as any known or suspected adverse effects.
- The biological evaluation shall include in vitro and/or in vivo tests, as appropriate.
- The results of the biological evaluation shall be used to establish the safety profile of the medical device.
- The biological evaluation shall be performed by qualified personnel using approved methods and procedures.
What are the benefits of ISO 10993-6:2016
There are many benefits to ISO 10993-6:2016, including:
- It provides guidance on the types of tests that should be performed to assess the potential local effects of medical devices after implantation.
- It helps ensure that medical devices are safe for use in humans.
- It can help reduce the risks associated with medical device implantation.
- It can help improve the quality of medical devices.
- It can help make sure that medical devices meet the needs of patients and doctors.
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