ISO 14155:1996
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ISO 14155:1996
23736

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 

  •  :  Withdrawn
     : 1996-02
  •  : 1
     : 12
  •  : ISO/TC 194 Biological and clinical evaluation of medical devices
  •  :
    11.100 Laboratory medicine

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