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Norm
ÖNORM EN ISO 14155
Issue date: 2021 11 15
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the cli...
Valid
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 109 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation.
This document specifies general requirements intended to
— protect the rights, safety and well-being of human subjects,
— ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
— define the responsibilities of the sponsor and principal investigator, and
— assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.
ÖNORM EN ISO 14155
2021 11 15
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:202...
Norm
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ÖNORM EN ISO 14155
2021 01 01
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:202...
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ÖNORM EN ISO 14155
2012 02 15
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:201...
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ÖNORM EN ISO 14155
2011 05 15
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:201...
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ÖNORM EN ISO 14155-2
2009 12 01
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans ...
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ÖNORM EN ISO 14155-1
2009 12 01
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 141...
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ÖNORM EN ISO 14155-2
2003 07 01
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans ...
Norm
ÖNORM EN ISO 14155-1
2003 07 01
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 141...
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Norm
Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices
Norm
Issue date :
2020 07 28
Clinical investigation of medical devices for human subjects — Good clinical practice