SS-EN-ISO-14155-2 › Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
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This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for theclinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of thisstandard and adherence to it will help in optimising the scientific validity and reproducibility of the results of aclinical investigation.This Standard does not apply to in vitro diagnostic medical devices.
To find similar documents by classification:
11.040.01 (Medical equipment in general)
11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)
Active implantable medical devices. Medical devices
Designation Name
SS-EN ISO 14155-2:2009
Revision Level
2009 EDITION
Status
Superseded
Publication Date
July 23, 2009
Language(s)
English
Page Count
24
International Equivalent
EN ISO 14155-2:2009(IDT); ISO 14155-2:2003(IDT)