IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission.
A list of the collateral and particular standards currently in force follows: (last updated 15 September 2016) For example, IEC 60601-1-9 for Environmentally Conscious Design of Medical Electrical Equipment published July 2007 is a collateral standard to IEC 60601-1 and has been developed drawing on extensive practical experience at Philips Medical Systems and Siemens Healthineers.
However, the European version (EN 60601-1:2006) requires compliance with the new IEC 60601-1-9 collateral standard by September 2009.
In the United States, nursing facilities are considered to be environments providing professional healthcare.
The American version of this collateral standard also places greater emphasis on a requirement that states that “inspection of the usability engineering file reinforce that the usability engineering process is necessary for validation of the instructions for use.” Devices typically mandated to use the new standard include oxygen concentrators, body-worn nerve and muscle stimulators, beds, sleep apnea monitors, and associated battery chargers prescribed for use at home.
This has been more particularly a concern during the transition to the third edition due to the indefinite adoption schedule of the new revision.