DIN EN ISO 14155-2:2009
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); English version of DIN EN ISO 14155-2:2009-11

Standard No.

DIN EN ISO 14155-2:2009

Release Date

2009

Published By

German Institute for Standardization

Status

Withdraw

Replace By

DIN EN ISO 14155:2012

Latest

DIN EN ISO 14155:2012

Scope

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation. This Standard does not apply to in vitro diagnostic medical devices.

DIN EN ISO 14155-2:2009 history

• 2012 DIN EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011
• 2009 DIN EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); English version of DIN EN ISO 14155-2:2009-11
• 1970 DIN EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
• 1970 DIN EN ISO 14155-2 E:2001-08 Clinical Studies of Medical Devices for Human Use Part 2: Clinical Study Protocol (Draft)

DIN EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); English version of DIN EN ISO 14155-2:2009-11 was changed to DIN EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011.