SS-EN-ISO-14155-1 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

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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.

To find similar documents by classification:

11.040.01 (Medical equipment in general)

11.100 (Laboratory medicine)

11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

Active implantable medical devices. Medical devices

Designation Name

SS-EN ISO 14155-1:2009

Revision Level




Publication Date

July 23, 2009



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International Equivalent

EN ISO 14155-1:2009(IDT); ISO 14155-1:2003(IDT)