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ISO 14155:1996

Clinical investigation of medical devices

Standard Details

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Status : WITHDRAWN
Standard Type: Main
Document No: ISO 14155:1996
Document Year: 1996
Pages: 12
Edition: 1
  • Section Volume:
  • ISO/TC 194. Biological evaluation of medical devices
  • ICS:
  • 11.100 Laboratory medicine

Life Cycle

WITHDRAWN

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WITHDRAWN
ISO 14155:1996
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