🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
ISO 14155-1:2003

ISO 14155-1:2003

$55.25

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

Published By Publication Date Number of Pages
ISO 2003-02 28
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

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.

Related products

ISO 14155-1:2003
$55.25