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ISO 14155:1996

Withdrawn Date published:

Warning: Withdrawn Standard. This document has been withdrawn without replacement. You may wish to search for a more up to date equivalent.

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.

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ISO 14155:1996

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