ISO 14155:1996 PDF
Clinical investigation of medical devices
Title (English):
ISO 14155:1996
Clinical investigation of medical devices
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 12
- Publication date:
- February 29, 1996
- Edition:
- ISO IS 14155 edition 1 version 1
- ICS:
- 11.100
Description (English):
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.
Technical details
- Technical committee
- ISO/TC 194 - Biological and clinical evaluation of medical devices
- SKU
- ISO 14155:1996
