ISO 14155-2:2003 PDF

ISO 14155-2:2003 PDF

Name:
ISO 14155-2:2003 PDF

Published Date:
05/15/2003

Status:
Active

Description:

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

Publisher:
International Organization for Standardization

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

SKU:

Choose Document Language:
$20.7
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1 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 optimising the scientific validity and reproducibility of the results of a clinical investigation.

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


File Size : 1 file , 280 KB
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 9
Published : 05/15/2003
Same As : ISO 14155-2:2003

History

ISO 14155:2020 Plus Redline
Published Date: 09/01/2020
Clinical investigation of medical devices for human subjects - Good clinical practice
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ISO 14155:2020
Published Date: 07/01/2020
Clinical investigation of medical devices for human subjects - Good clinical practice
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ISO 14155:2011
Published Date: 02/01/2011
Clinical investigation of medical devices for human subjects - Good clinical practice
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ISO 14155-2:2003
Published Date: 05/15/2003
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
$20.7
ISO 14155-1:2003
Published Date: 02/15/2003
Clinical investigation of medical devices for human subjects - Part 1: General requirements
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