0 Items
My account
Phone: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Standards sales: prodaja@iss.rs Education: iss-edukacija@iss.rs Information about standards: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Main menu

ISO 14155-2:2003

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

May 16, 2003
95.99   Withdrawal of Standard   Jan 21, 2011

General information

95.99     Jan 21, 2011

ISO

ISO/TC 194

International Standard

11.100.20  

English  

Buying

Withdrawn

Language in which you want to receive the document.

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WITHDRAWN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WITHDRAWN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
Jan 21, 2011

REVISED BY

ABANDON
ISO/WD 14155-2

WITHDRAWN
ISO 14155:2011

National adoptions

SRPS EN ISO 14155-2:2011  
ISS

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

95.99   Withdrawal of Standard

Z076 more