Medical Device Testing and Evaluation
Medical devices are subject to many regulatory standards from general requirements for basic safety and essential performance (60601-1) with inclusion of several collateral standards dealing with operational characteristics (e.g. 60601-1-2 for EMC; 60601-1-11 for home medical, etc.) and vertical standards dealing with specific aspects of the device (particular standards often referred to as -2 standards). Test and evaluation of the applicable requirements stem from Edition 3 (currently in effect for most regions) with a risk based review to assess applicability of the standard and to identify areas not covered by the standards.
