ISO 10993-10:2021 Biological evaluation of medical devices —
Part 10: Tests for skin sensitization
In the process of developing a new medical device, it is important to consider how the device will interact with human tissues. In particular, you need to ensure that the device will not cause an allergic reaction in patients. The ISO 10993-10:2021 standard provides guidance on how to test for skin sensitization.
What is ISO 10993-10:2021 ?
ISO 10993-10:2021 is an international standard that specifies requirements and provides guidance for the biological evaluation of medical devices with respect to their potential to cause skin sensitization.
The standard applies to all medical devices that come into contact with the skin, including those that are implanted, inserted, or otherwise introduced into the body.
ISO 10993-10:2021 specifically deals with the tests for skin sensitization. It does not deal with other aspects of the biological evaluation of medical devices, such as genotoxicity or irritation.
The standard is intended to be used by manufacturers, regulators, and other interested parties in the design, development, and evaluation of medical devices.
ISO 10993-10:2021 is the first part of a three-part series on biological evaluation of medical devices. The other two parts are ISO 10993-1:2009, which deals with general requirements, and ISO 10993-18:2013, which deals with animal welfare issues.
What are the requirements of ISO 10993-10:2021 ?
The standard ISO 10993-10:2021 specifies requirements and provides guidance for the conduct of skin sensitization tests using in vitro and/or in vivo methods.
The standard is applicable to all medical devices, including those that come into contact with the skin, that have the potential to cause sensitization (i.e. an allergic reaction).
In vitro methods are suitable for testing substances that are known to be or are suspected of being skin sensitizers. In vivo methods are generally considered to be more predictive of clinical sensitization, but they are also more expensive and time-consuming.
The decision on which method(s) to use should be based on a risk assessment of the device and its intended use.
ISO 10993-10:2021 does not apply to products that are not medical devices, such as cosmetics or pharmaceuticals.
What are the benefits of ISO 10993-10:2021 ?
The benefits of ISO 10993-10:2021 include:
Establishes international consensus on tests for skin sensitization
- Provides guidance on how to select the most appropriate test method(s) based on the device material(s)
- Helps ensure that medical devices are safe for use by patients with sensitive skin
- Helps reduce the risk of adverse reactions in patients with sensitive skin
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