BS EN ISO 14155-2:2009 PDF

BS EN ISO 14155-2:2009 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.

BS EN ISO 14155-2:2009 does not apply to in vitro diagnostic medical devices.



Cross References:
EN ISO 14155-1:2003
ISO 14155-1:2001
EN ISO 14971
EN ISO 10993
93/42/EEC
90/385/EEC


All current amendments available at time of purchase are included with the purchase of this document.

File Size :	1 file , 810 KB
ISBN(s) :	9780580690112
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	20
Product Code(s) :	30209183, 30209183, 30209183
Published :	01/31/2010