ISO 14155-2:2003

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

Publication date: 16 maj 2003

95.99 Withdrawal of Standard 21 jan 2011

General information

Current stage: 95.99 Effective date: 21 jan 2011

Originator: ISO

Owner: ISO/TC 194

Type: International Standard

ICS: 11.100.20

Gjuha: anglisht

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Statusi: Shfuqizuar

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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 optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 14155:1996

NOW

WITHDRAWN
ISO 14155-2:2003
95.99 Withdrawal of Standard
21 jan 2011

REVISED BY

ABANDON
ISO/WD 14155-2

WITHDRAWN
ISO 14155:2011