EN ISO 14155:2011
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

Standard No.

EN ISO 14155:2011

Release Date

2011

Published By

European Committee for Standardization (CEN)

Status

Be replaced 2020-11

Replace By

EN ISO 14155:2020

Latest

EN ISO 14155:2020

Scope

This International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes

EN ISO 14155:2011 history

• 2020 EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
• 2011 EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)