EVS-EN ISO 18113-1:2024

ISO 18113-1 defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. ISO 18113-1 contains a comprehensive list of terms and definitions necessary to develop the labelling for IVD medical devices. These apply to all parts of the ISO 18113 series.

Internationally agreed-upon definitions of important concepts promote greater consistency in IVD medical device labelling. While the goal is to standardize the terminology used in IVD medical device labelling to the extent possible, it is also recognized that current national and regional usage by medical laboratories, healthcare providers, patients and regulatory authorities should be considered.

The ISO 18113 series specifies requirements for information supplied by the manufacturer of IVD medical devices. It consists of five parts, allowing it to address the specific needs of professional users and self-testing users most properly. Furthermore, since manufacturers provide different types of information for IVD reagents and instruments, their requirements are addressed in separate parts of the ISO 18113 series.

ISO 18113-1:2022 text has been approved in Europe as EN ISO 18113-1:2024 without any changes.