ISO 14155:1996

Clinical investigation of medical devices

Clinical investigation of medical devices

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Clinical investigation of medical devices

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.

Edition1996
Published Date1996
Published ByInternational Standardization Organisation
Page Count12