SR EN ISO 14155-2:2009

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

1 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.

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General information

Status : Withdrawn
Approval date : 12/15/2009
Publish date : 12/17/2009
Withdrawal date : 7/29/2011
Number of pages : 16
ICS : 11.100.20 Biological evaluation of medical devices
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 14155-2:2004
Normative reference SR EN ISO 14155-1:2009
Replaced by SR EN ISO 14155:2011