Global InformationISO 14155 information
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ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice
This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes. However, it does not apply to in vitro diagnostic medical devices.
This standard was developed by ISO technical committee ISO/TC 194. ISO 14155 was published in its second edition in February 2011. The third edition was released in July 2020.