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Norm
ÖNORM EN ISO 14155-1
Issue date: 2003 07 01
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
This part of ISO 14155 defines procedures for the conduct and performance of clinical investigations of
medical devices. It specifies general requirements intended to
...
Withdrawn: 2010 01 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 30 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 14155 defines procedures for the conduct and performance of clinical investigations of
medical devices. It specifies general requirements intended to
protect human subjects,
ensure the scientific conduct of the clinical investigation,
assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in
the conformity assessment of medical devices.
This part of ISO 14155
a) 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,
b) specifies requirements for the organization, conduct, monitoring, data collection and documentation of the
clinical investigation of a medical device,
c) is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is
being assessed in human subjects.
This part of ISO 14155 is not applicable to in vitro diagnostic medical devices.
ÖNORM EN ISO 14155
2021 11 15
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Norm
ÖNORM EN ISO 14155
2021 01 01
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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
ÖNORM EN ISO 14155-1
2003 07 01
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 141...
Norm
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Norm
Issue date :
2003 05 16
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
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
Norm
Issue date :
2009 12 01
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)