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.
Status: WithdrawnPublication date: 1996-02
Edition: 1Number of pages: 12
Technical Committee: ISO/TC 194 Biological and clinical evaluation of medical devices
- ICS :
- 11.100 Laboratory medicine
ISO 14155:1996Stage: 95.99
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