ISO 13485 ISO 13485:2016 is the latest version of the standard created by the International Organization for Standardization (ISO). The purpose of revisions to the ISO 13485 standard is to promote a process of continuous improvement. The ISO 13485:2016 standard aims to ensure that medical devices are safe, effective, and of high quality. https://iasiso-middleeast.com/EG/blog/iso-13485/