DIN EN ISO 10993-1:2026

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025); German version EN ISO 10993-1:2025

The most important concern of this document is the protection of humans from possible biological risks arising from the use of medical devices. The document has been compiled from numerous international and national standards and guidelines relating to the biological evaluation of medical devices. It is intended as a description of the biological evaluation of medical devices within a risk management process, as part of the comprehensive evaluation and development of medical devices. This approach combines the review and evaluation of existing data from all sources with, where necessary, the selection and application of additional tests, allowing a complete assessment to be made of the biological response to each medical device according to its safety in use.