ISO 10993

The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. For the purpose of the ISO 10993 family of standards, biocompatibility is defined as the "ability of a medical device or material to perform with an appropriate host response in a specific application".

Part 1 of the Standard provides general information about the biocompatibility evaluation process. The current version was published in 2018, replacing the previous version published in 2009. A new version is expected to be published by the end of 2025.

Table A.1 is used to classify medical devices according to the nature (e.g. implant device) and duration (e.g. long term contact of more than 30 days) of their interaction with the human body. This is a core aspect of the evaluation process that will determine which endpoints should be evaluated. However, the relevant endpoints should be decided as part of a risk-evaluation process that goes beyond the cageroziation of the medical device. Even if an endpoint is excluded by the categorization, it may be necessary if the risk-evaluation recommends it.

The Food and Drug Administration (FDA) published a guidance document to support the evaluation process, clarifying their interpretation of some key aspects of the normative .

With the exception of Part 1, each part focuses on a specific aspect of the biocompatibility evaluation process. The title indicates the publication year of the latest edition. Withdrawn parts are no longer relevant and will not be maintained or updated.

ISO 10993-1: 2018. Evaluation and testing within a risk management process

ISO 10993-2: 2022. Animal welfare requirements

ISO 10993-3: 2014. Tests for genotoxicity, carcinogenicity and reproductive toxicity