DANSK DS/EN ISO 14155-2 PDF

DANSK DS/EN ISO 14155-2 PDF

Name:
DANSK DS/EN ISO 14155-2 PDF

Published Date:
09/08/2009

Status:
[ Withdrawn ]

Description:

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

Publisher:
Dansk Standard

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

SKU:

Choose Document Language:
$19.2
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W/D S/S BY DS/EN ISO 14155

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.


Edition : 09
File Size : 1 file , 900 KB
Number of Pages : 26
Product Code(s) : DS-026, DS-026
Published : 09/08/2009

History


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