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Norm
ISO 14155:1996
Issue date: 1996 02 29
Clinical investigation of medical devices
Pertains to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment. Specifies the requirements for conducting t...
Withdrawn: 2003 02 26
Publisher:
International Organization for Standardization
Format:
Digital | 12 Pages
Language:
English
Currently valid:
ICS
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.
ISO 14155:2020
2020 07 28
Clinical investigation of medical devices for human subjects — Good clinical practice
Norm
ISO 14155:2011
2011 01 21
Clinical investigation of medical devices for human subjects — Good clinical practice
Norm
ISO 14155-2:2003
2003 05 16
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Norm
ISO 14155-1:2003
2003 02 26
Clinical investigation of medical devices for human subjects — Part 1: General requirements
Norm
Norm
Issue date :
2003 05 16
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Norm
Issue date :
2003 02 26
Clinical investigation of medical devices for human subjects — Part 1: General requirements