ISO 14155

There is a standard called ISO 14155 related to the clinical testing of medical devices involving human subjects. The standard is called “ISO 14155:2011 Clinical investigation of medical devices for human subjects — Good clinical practice.”

Guidelines for conducting clinical research are established by the International Organization for Standardization 14155 to ensure the safety of human participants and the generation of reliable clinical data. This standard applies to clinical trials designed, conducted, documented, and reported on to assess the efficacy and safety of medical devices for regulatory purposes.