[article originally published on June 19, 2025, updated with the publication of Regulation (EU) 2025/1234] Implementing Regulation (EU) 2021/2226, which regulates the electronic supply of.
This article’s objective is to clarify the Standards’ references. As you will have noticed from your research: the names of the standards are difficult to grasp and the explanations are not easy to find. This article gives the definitions of the main terms, using information from ISO where available.
This article presents the “philosophy” of the 7 principles of quality management. Each principle is illustrated with a quote, for ease of understanding.
Summary of IEC 60601-1: General requirements for the basic safety and essential performance of medical electrical equipment.
