EN 60601-1-11 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the home healthcare environment. The safety of medical electrical equipment can be a cause for concern.
The potential lack of training for the use of medical electrical equipment or a medical electrical system needs to be addressed in the development of the documents and in the relevant marking on the equipment itself. EN 60601-1-11 gives special guidance on how this should be addressed in the instructions for use.
The international standard has been approved in Europe as EN 60601-1-11:2015 without any changes and it supersedes EN 60601-1-11:2010.
The main changes in the new edition are:
— correction of the test method for relative humidity control at temperatures above 35 °C,
— redrafting of subclauses that altered instead of adding to the general standard or other collateral standards,
— harmonizing with the changes to the amendments to the general standard and other collateral standards.
