ISO 14971

ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard,[1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.[2]

The current ISO 14971 edition was published in December 2019.

  1. ^ "FOREWORD - SUPPLEMENTARY INFORMATION". www.iso.org/foreword-supplementary-information.html.
  2. ^ ISO Catalogue: Medical devices -- Application of risk management to medical devices