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Norm

ISO 14155-1:2003

Ausgabedatum: 2003 02 26

Clinical investigation of medical devices for human subjects — Part 1: General requirements

ISO 14155-1:2002 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to: protect ...
ZURÜCKGEZOGEN: 2011 01 21
Herausgeber:
International Organization for Standardization
Format:
Digital | 21 Seiten
Sprache:
Englisch
Aktuell Gültig:

ISO 14155-1:2002 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.

ISO 14155-1:2002

  1. 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,
  2. specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device,
  3. is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.

ISO 14155-1:2002 is not applicable to in vitro diagnostic medical devices.

ISO 14155:2020
2020 07 28
Clinical investigation of medical devices for human subjects — Good clinical practice
Norm
ISO 14155:2011
2011 01 21
Clinical investigation of medical devices for human subjects — Good clinical practice
Norm
ISO 14155-1:2003
2003 02 26
Clinical investigation of medical devices for human subjects — Part 1: General requirements
Norm
ISO 14155:1996
1996 02 29
Clinical investigation of medical devices
Norm
Historie aufklappen
Norm
ISO 14155:2011
Ausgabedatum : 2011 01 21
Clinical investigation of medical devices for human subjects — Good clinical practice