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  3. AAMI/ISO 14155-2:2003/(R)2008 PDF

AAMI/ISO 14155-2:2003/(R)2008 PDF

AAMI/ISO 14155-2:2003/(R)2008 PDF

Name:
AAMI/ISO 14155-2:2003/(R)2008 PDF

Published Date:
12/19/2008

Status:
Active

Description:

Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans

Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$26.4
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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.
ANSI : ANSI Approved
File Size : 1 file , 120 KB
ISBN(s) : 1570202001
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 19
Published : 12/19/2008

History

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Clinical investigation of medical devices for human subjects - Good clinical practice
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AAMI/ISO 14155-2:2003/(R)2008
AAMI/ISO 14155-2:2003/(R)2008
Published Date: 12/19/2008
Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans
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AAMI/ISO 14155-1:2003/(R)2008
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