95.99 Withdrawal of Standard Feb 26, 2003
ISO
ISO/TC 194 Biological and clinical evaluation of medical devices
International Standard
11.100 Laboratory medicine
Withdrawn
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.
WITHDRAWN
ISO 14155:1996
95.99
Withdrawal of Standard
Feb 26, 2003