DIN EN ISO 14155-1-2009 人体适用的医疗设备的临床调查.第1部分:一般要求(ISO 14155-1:2003)EN ISO 14155-1:2009的德文版本
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); English version of DIN EN ISO 14155-1:2009-11
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.