The Basics of IEC 60601-1 Based Standards 
(Updated February 23, 2006)

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IEC 60601-1 Electrical Medical Device Standards are the International Standards used for the basis of most national and European Standards for Electrical Medical Devices.  IEC 60601-1 is the basis of the U.S. UL 60601-1 (previously UL 2601-1) standard, the European EN 60601-1 standard, and the Canadian C22.2 No. 601.1 standard. 

To align with the European numbering system IEC 601-1 was changed to IEC 60601-1.

The IEC 60601-1 set of standards are broken up into three distinct areas.  The first area is the basic standard IEC 60601-1.  This is the general requirement for all electrical medical based products.  The second area is the collateral standards, which cover across the board issues such as combining into a system with other devices, EMC, radiation protection, and programmable electronic medical systems (software, firmware, etc.).  The standard numbers are IEC 60601-1-1, -1-2, -1-3, and -1-4 respectively.  There are additional IEC 60601-1-X standards in the series. The third area is the particular standards that deal with a specific type of medical device. The particular standards are identified as IEC 60601-2-XX where XX identifies the particular standard number for the particular type of medical equipment.  An example would be IEC 60601-2-2 is the particular standard for High Frequency Surgical Devices.  

The second edition of IEC 60601-1 was published in 1988 and was adopted as an EN standard in 1990.  Amendments A1, A11, and A12 were added to IEC60601-1 in 1990 & 1991 and were adopted as part of the EN standard in 1993.  Amendment A2 is the most important Amendment to date because it added all the requirements to align the standard much closer to the Medical Device Directive Essential requirements (Annex I of the MDD).  EN60601-1 was adopted with this amendment in 1995. Amendment A13 was incorporated into EN60601-1 in 1996.  The Third Edition of IEC 60601-1 was published December 15, 2005 and will likely be adopted by many national standards organizations in 2006.   After that occurs the Certification Agencies will determine how they will certify products to that stadnard.

UL 2601-1, Second Edition incorporates Amendment 2 of IEC 60601-1 and was published in October 1997.  There is an effective date of compliance of February 6, 1999 to these updates except for SI units per subclause 6.3.9 g) that is effective by February 6, 2004 for UL 2601-1.

IEC 60601-1-1 went to Second Edition in December 2000 which made the system requirements more stringent when dealing with multiple portable socket outlets (i.e. power strips on a portable cart).

View a list of IEC 60601-1 based standards.   Also, view a list of IEC 60601-1 based standards that are under development.