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.
The latest revision of the standard has been released in Feb, 2011 and hence, the current version of the standard is ISO 14155:2011.
The standard ISO 14155:2011 is assessable standard and hence, certifiable. The standard regards good clinical practices and protocols for the clinical investigations and plans of medical devices. The assessment is carried out following defined protocols in this international standard.
Independent assessment bodies carry out independent assessments following auditing principles and practices and protocols in this International Standard.
- International Organization for Standardisation
- List of International Organization for Standardization standards
- Good Clinical Practice