Standard: AAMI 14155-2

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS—PART 2: CLINICAL INVESTIGATION PLANS

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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 optimizing the scientific validity and reproducibility of the results of a clinical investigation.

This Standard does not apply to in vitro diagnostic medical devices.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 14155-2
Publish Date: 2003-01-01
Page Count: 19
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: NO
Status: Inactive
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