ISO 14155:1996

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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.

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International Organization for Standardization [iso]

Historical

Clinical investigation of medical devices

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Historical

ISO 14155:1996

Clinical investigation of medical devices

Are the documents at the ANSI Webstore in electronic Adobe Acrobat PDF format only?

Useful Links

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Our Contacts