Tag Archives: Hazard Mitigation
FAQ: Risk Management for IEC 60601-1
FAQ: Risk Management for IEC 60601-1 What you need to know about Risk Management for medical devices What is Risk Management in 60601? Risk management is a series of risk evaluations performed by the manufacturer, based on ISO 14971, which are undertaken and documented throughout the design, production and post-production process of medical equipment. The... Read More
IEC/EN/UL/CSA 61010-1 Third Edition
Since the release of the 3rd Edition, there have been varying interpretations regarding if and when a Risk Assessment is a requirement or merely an option. The disagreements have occurred between different Certification Bodies, between test houses and manufacturers, and even within specific discrete entities. Given this previous uncertainty and the possibility of inconsistently imposed... Read More
