ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
In the world of medical device regulation, the International Organization for Standardization (ISO) 10993 series of standards is widely recognized as the go-to guidance for addressing the potential risks posed by interactions between blood and medical devices. The most recent update to this series, ISO 10993-4:2017, provides specific guidance on the selection of tests that should be performed to assess these risks. In this article, we’ll provide an overview of the key changes in ISO 10993-4:2017 and what they mean for manufacturers.
What is ISO 10993-4:2017?
ISO 10993-4:2017 provides guidance on the selection of tests to be used in the biological evaluation of medical devices with respect to their interactions with blood.
The standard applies to all medical devices that come into contact with blood, including those that are implantable, invasively inserted, or used externally.
The tests described in ISO 10993-4:2017 are divided into two categories:
- those that assess the potential for damage to red blood cells (hemolysis), and
- those that evaluate the potential for clotting (coagulation).
Each test has specific requirements that must be met in order for the results to be considered valid.
ISO 10993-4:2017 is one of a series of standards that make up the ISO 10993 family of standards for the biological evaluation of medical devices.
What are the requirements of ISO 10993-4:2017
The requirements of ISO 10993-4:2017 are as follows:
- The test methods selected shall be appropriate to the medical device and its intended use.
- The tests shall be able to detect any adverse reaction of the medical device with blood components, including cells, proteins and coagulation factors.
- The tests shall be able to identify reactions that may occur at the site of contact between the medical device and blood, as well as systemic reactions.
- The tests shall be able to assess the potential for thrombosis (blood clotting) and/or embolism (blockage of blood vessels).
- The results of the tests shall be used to evaluate the safety of the medical device in terms of its potential to cause adverse reactions in patients.
What are the benefits of ISO 10993-4:2017
The benefits of ISO 10993-4:2017 include:
Helps to ensure the safety of medical devices that come into contact with blood
- Provides guidance on the selection of tests for interactions with blood
- Can be used by manufacturers to help support their product claims
- Helps to ensure that medical devices are compatible with blood and do not pose a risk to patients
- Can be used by regulators to assess the safety of medical devices
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