What is ISO 10993-4:2018 ?

ISO 10993-4:2018 is a crucial technical standard that ensures the biocompatibility of medical devices. It provides a standardized framework for the selection and qualification of tests related to biocompatibility, which helps to evaluate the potential risks associated with contact between medical devices and biological systems.

ISO 10993-4 is divided into four parts, each covering a different aspect of the standard. The first part, ISO 10993-4.1, provides general guidance for the selection and qualification of tests for biocompatibility. The second part, ISO 10993-4.2, defines the criteria for evaluating the biocompatibility of medical devices. The third part, ISO 10993-4.3, specifies the procedures for conducting the tests.

The key components of ISO 10993-4 include:

* A set of criteria for evaluating the biocompatibility of medical devices

* A test method for evaluating the biocompatibility of medical devices

* A test procedure for evaluating the contact angle between a medical device and the body surface

* A set of requirements for the documentation of the testing process

By following the guidelines and requirements set out in ISO 10993-4, medical device manufacturers can ensure that their products are biocompatible and safe for use in various biological environments. Adhering to this standard is essential for protecting patient safety and ensuring the effectiveness of medical devices.