ISO 14155:1996

Clinical investigation of medical devices ISO 14155:1996

Publication date:   Feb 29, 1996

95.99 Withdrawal of Standard   Feb 26, 2003

General information

95.99 Withdrawal of Standard   Feb 26, 2003

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100   Laboratory medicine

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Scope

Pertains to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment. Specifies the requirements for conducting the clinical investigation and documentation. Provides the framework for systematic written procedures for the organization, design, implementation and data collection.

Life cycle

NOW

WITHDRAWN
ISO 14155:1996
95.99 Withdrawal of Standard
Feb 26, 2003

REVISED BY

WITHDRAWN
ISO 14155-1:2003

WITHDRAWN
ISO 14155-2:2003