This International Standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations

Clinical trial

Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...

 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.

Assessment

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.

Certification

Independent assessment bodies carry out independent assessments following auditing principles and practices and protocols in this International Standard.

See Also

• International Organization for Standardisation
• List of International Organization for Standardization standards
• Good Clinical Practice
  Good clinical practice
  Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...