AAMI CR500:2019

This document provides information regarding concepts and principles that underlie the IEC 60601 series of standards. Given the size and complexity of the IEC 60601 series, it is a challenge to gain more than a superficial understanding of what the 60601 series of standards encompasses, let alone why it matters. Therefore, a key objective of this document is to provide stakeholders with sufficient information about the 60601 series to grasp its significance and value. At the same time, it is important to know what the 60601 series excludes, so that stakeholders can understand the role it plays in the broader context of assuring the safety and effectiveness of MEE/MESs. This document is intended to clarify and to point out the importance of the series as well as to provide guidance to understanding and to implementing the series. No annex