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Norm
ÖNORM EN ISO 14155-1
Issue date: 2009 12 01
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
This part of ISO 14155 specifies requirements for the conduct of a clinical investigation such that it establishes the performance
of the medical device during the clini...
Withdrawn: 2011 05 15
Publisher:
Austrian Standards International
Format:
Digital | 31 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 14155 specifies requirements for the conduct of a clinical investigation such that it establishes the performance
of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device. It specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device and is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.
ÖNORM EN ISO 14155
2021 11 15
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:202...
Norm
ÖNORM EN ISO 14155
2021 01 01
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:202...
Norm
ÖNORM EN ISO 14155
2012 02 15
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:201...
Norm
ÖNORM EN ISO 14155
2011 05 15
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:201...
Norm
ÖNORM EN ISO 14155-1
2009 12 01
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 141...
Norm
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ÖNORM EN ISO 14155-1
2003 07 01
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 141...
Norm
Norm
Issue date :
2003 05 16
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Norm
Issue date :
2011 05 15
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
Norm
Issue date :
2003 02 26
Clinical investigation of medical devices for human subjects — Part 1: General requirements
