The main standard that applies to medical devices is BS EN / IEC 60601, which is a group of standards covering the electrical safety, essential performance and electromagnetic compatibility of medical electrical equipment. This group of standards include:
BS EN / IEC 60601-1, the base standard covering the general requirements
BS EN / IEC 60601-1-xx, these are the collateral standards
BS EN / IEC 60601-2-xx, the particular standards. These covers the requirements for a specific product.
The team at Cranage have years of experience in carrying out medical device EMC and Safety testing to BS EN / IEC 60601, as well as the common ones required below:
BS EN / IEC 60601-1 General requirements for basic safety and essential performance
BS EN / IEC 60601-1-2 EMC requirements and tests
BS EN / IEC 60601-2-2 Basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
BS EN / IEC 60601-2-10 Safety requirements for nerve and muscle stimulators
BS EN / IEC 61010-1 General requirements for safety
BS EN / IEC 61010-2-101 Safety requirements for in vitro diagnostic medical equipment
BS EN / IEC 61326-2-6 Electrical equipment for measurement, control and lab- EMC requirements. Particular requirements for IVD medical equipment
Our complete range of accredited testing can be viewed on our UKAS schedule or alternatively get in touch with us to discuss your medical product testing requirements.
Follow this link to the Government website for further details on medical device regulations, including details on CE and UKCA marking.