ISO 14155
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.
History
the first edition of ISO 14155-1 was published on 15 February 2003. The latest revision of the standard was released in February 2011 and hence, the current version of the standard is ISO 14155:2011.
Main requirements of the standard
The ISO 14155[1] adopts the structure in the following breakdown:
- Scope
- Normative references
- Terms and definitions
- Ethical considerations
- Clinical investigation planning
- Clinical investigation conduct
- Suspension, termination and close-out of the clinical investigation
- Responsibilities of the sponsor
- Responsibilities of the principal investigator
Assessment
The standard ISO 14155:2011 is an assessable standard and hence is 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
References
External links
- ISO 14155—Clinical investigation of medical devices for human subjects -- Good clinical practice
- ISO TC 194—Biological and clinical evaluation of medical devices