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About This Item
Full Description
- 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 BS EN ISO 14155-1:2009
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.
BS EN ISO 14155-1:2009 is not applicable to in vitro diagnostic medical devices.
Cross References:
ISO 14155-2
ISO 14971
ISO 10993
93/42/EEC
90/385/EEC
All current amendments available at time of purchase are included with the purchase of this document.
Document History
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BS EN ISO 14155:2020
Clinical investigation of medical devices for human subjects. Good clinical practice- Most Recent
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BS EN ISO 14155:2011
Clinical investigation of medical devices for human subjects. Good clinical practice- Historical Version
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BS EN ISO 14155-1:2009
viewing
Clinical investigation of medical devices for human subjects-General requirements- Historical Version
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BS EN ISO 14155-2:2009
Clinical investigation of medical devices for human subjects-Clinical investigation plans- Historical Version
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BS 08/30116059 DC
BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice- Historical Version
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BS EN ISO 14155-2:2003
Clinical investigation of medical devices for human subjects-Clinical investigation plans- Historical Version
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BS EN ISO 14155-1:2003
Clinical investigation of medical devices for human subjects-General requirements- Historical Version
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BS EN 540:1993
Clinical investigation of medical devices for human subjects- Historical Version