ISO 10993-11:2017 Biological evaluation of medical devices —
Part 11: Tests for systemic toxicity
In order to ensure the safety of medical devices, they must undergo a series of tests to assess their potential toxicity. The ISO 10993-11:2017 standard specifies the requirements for such tests.
What is ISO 10993-11:2017?
ISO 10993-11:2017 is the international standard for biological evaluation of medical devices. The standard provides guidance on how to conduct tests for systemic toxicity, which is the potential for a device to cause adverse effects throughout the body.
Systemic toxicity tests are typically conducted on animals, and they can help to assess the potential risks of a device before it is used on humans. These tests can also be used to monitor the safety of a device during its development and after it has been approved for use.
ISO 10993-11:2017 covers tests for acute and subacute systemic toxicity, as well as chronic toxicity. The standard also provides guidance on how to interpret the results of these tests.
If you are involved in the development or testing of medical devices, ISO 10993-11:2017 is an essential resource.
What are the requirements of ISO 10993-11:2017?
The standard ISO 10993-11:2017 provides requirements for the biological evaluation of medical devices with respect to their potential systemic toxicity.
Systemic toxicity is the adverse effects that occur when a medical device enters the bloodstream and circulates throughout the body. This can happen when a medical device is implanted or when it comes into contact with blood or body fluids.
Systemic toxicity can range from minor side effects, such as headaches and dizziness, to more serious effects, such as organ damage and death.
To assess the potential systemic toxicity of a medical device, ISO 10993-11:2017 recommends a number of tests, including tests for acute and chronic toxicity, mutagenicity, and carcinogenicity.
The standard also provides guidance on how to interpret the results of these tests and how to use them to assess the risk of systemic toxicity associated with a particular medical device.
What are the benefits of ISO 10993-11:2017?
One of the benefits of ISO 10993-11:2017 is that it provides guidance on how to assess the potential for systemic toxicity of medical devices. This helps to ensure that medical devices are safe for use in humans.
Another benefit of this standard is that it can help to improve the design of medical devices. By understanding the potential for systemic toxicity, designers can create devices that are less likely to cause adverse effects in users.
ISO 10993-11:2017 can also help manufacturers to select materials that are less likely to cause systemic toxicity. This can reduce the risks associated with medical device use.
Overall, ISO 10993-11:2017 helps to improve the safety of medical devices by providing guidance on how to assess and manage the risks of systemic toxicity.
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