ISO 14155:1996


Note: Latest version: ISO 14155:2020

Existing or new amendments and versions must be purchased separately.

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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.

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  • Standard from ISO
  • Published:
  • Withdrawn:
  • Period for objection until:
  • Edition: 1
  • Document type: IS
  • Pages
  • Publisher: ISO
  • Distributor: ISO
  • ICS: 11.100
  • International TC: ISO/TC 194

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