Reference number
ISO 14155:1996
© ISO 2025
ISO 14155:1996
Clinical investigation of medical devices
Edition 1
1996-02
Withdrawn
Withdrawn (Edition 1, 1996)

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     : Withdrawn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
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 12
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100 
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