SR EN ISO 14155-2:2004

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

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.

General information

Status : Withdrawn
Approval date : 11/30/2004
Publish date : 12/1/2004
Withdrawal date : 2/28/2010
Number of pages : 18
ICS : 11.040.01 Medical equipmet in general
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaced by SR EN ISO 14155-2:2009