Standard

ISO 14155:1996

Withdrawn

Note: Latest version: ISO 14155:2020

Existing or new amendments and versions must be purchased separately.

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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.

Products specifications

  • 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  • Withdrawn: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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