SS-EN-ISO-14155-2 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

SS-EN-ISO-14155-2 - 2009 EDITION - SUPERSEDED
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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
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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Superseded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)