ISO 14155:1996

Clinical investigation of medical devices

General information

Number of Pages:

Edition: 1 (Monolingual)	ICS: 11.100
Status: Withdrawn	Stage: 95.99 (2003-02-26)
TC/SC: TC 194

Abstract

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.

Revision information

Revised by: ISO 14155-1:2003

Revised by: ISO 14155-2:2003

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