EN60601-1 - Safety of medical electrical equipment

EN60601-1 is a safety standard that covers the safety and performance requirements for any equipment that will be operated within an area in which patients will be cared for. It is a medical safety standard applicable to medical electrical equipment such as surgical and monitoring devices. This patient 'area' is deemed to be a space with surfaces likely to be contacted by the patient or an attendant who can contact the patient. 

The International Electrotechnical Commission (IEC) and the International Organisation for standardization (ISO) are the main agencies responsible for electrical safety standards. A safety standard which starts with IEC such as IEC60601-1 are often called a "harmonized standard". However despite the 2 main agencies continuing to pursue hamonization, regional variations remain and hence certain products such as power supplies that are intended to be shipped and used in multiple markets will need to show all the required certifications. Often a product meeting any given standard such as 60601-1 may be identified with the standards number prefixed with EN, UL, CSA to show the country where it is certified. Therefore EN60601-1 is the safety of medical electrical equipment for Europe. CSA60601-1 is the same standard for Canada, UL60601-1 is for the USA.

IEC60601-1 follows the same fundamental requirements set out in IEC60950-1 but has increased levels of protection for creepage and clearance, as well as isolation and insulation and leakage current.