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.
General information
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Status: WithdrawnPublication date: 1996-02Stage: Withdrawal of International Standard [95.99]
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Edition: 1Number of pages: 12
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Technical Committee :ISO/TC 194ICS :11.100
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Life cycle
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Now
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Revised by
WithdrawnISO 14155-1:2003
WithdrawnISO 14155-2:2003