ISO 14155-1:2003

Clinical investigation of medical devices for human subjects — Part 1: General requirements

Publication date:   Feb 26, 2003

95.99 Withdrawal of Standard   Jan 21, 2011

General information

95.99 Withdrawal of Standard   Jan 21, 2011

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100.20   Biological evaluation of medical devices

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Scope

ISO 14155-1:2002 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to:
protect human subjects;ensure the scientific conduct of the clinical investigation;assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.
ISO 14155-1:2002
specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device,specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device,is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.
ISO 14155-1:2002 is not applicable to in vitro diagnostic medical devices.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 14155:1996

NOW

WITHDRAWN
ISO 14155-1:2003
95.99 Withdrawal of Standard
Jan 21, 2011

REVISED BY

ABANDON
ISO/PWI 14155-1

WITHDRAWN
ISO 14155:2011