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 

  • Status
     :  Withdrawn
    Publication date
     : 1996-02
  • Edition
     : 1
    Number of pages
     : 12
  • Technical Committee
     : ISO/TC 194 Biological and clinical evaluation of medical devices
  • ICS
     :
    11.100 Laboratory medicine

Life cycle


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