A review of the standard for medical electrical equipment and medical power supplies and how it has changed over the years.
What is IEC 60601-1?
IEC 60601-1 is the safety and performance standard set by the International Electrotechnical Commission (IEC) that medical electrical equipment must comply with before use. The IEC is a collaboration of experts from across the world that sets international standards for electrotechnology components, systems, and equipment that companies typically need to comply with in order to ensure their product is safe to use.
There are different versions of IEC 60601-1 across the USA, Canada, and the EU, but they all contain very similar information about medical safety guidelines. The main purpose of IEC 60601-1 is to reduce risk when using the product as much as possible for both patient and operator, as well as making product design and use more user-friendly.
In terms of power supplies, they are considered a component that will be used in the final piece of medical electrical equipment. Since the medical product will need to comply IEC 60601-1, the power supply will need to comply as well in order to remain compliant. IEC 60601-1 has been revised several times to keep it up to date with the latest developments with technology.
What is the timeline of IEC 60601?
1977 – Edition 1.0
The IEC first set up the standards for electrical medical equipment in 1977 with their publication of IEC 60601-1 (known as IEC 601 at the time). The primary goal of this standard was to create standards for medical electrical equipment for the general medical environment that is being used by qualified personnel. It provides guidelines for safe and reliable operation and has the ultimate goal of removing as much risk as possible during the use and operation of medical electrical equipment.
- 1984: The first amendment to IEC 60601-1 was added in 1984. This amendment addressed requirements for medical electron accelerators.
1988 – Edition 2.0
The first full revision to IEC 60601-1 occurred in 1988. This revision focused on the safety in terms of vicinity to the patient.
- 1991: First amendment to the 2nd edition included updates to address evolving technology of electromedical equipment.
- 1995: Second amendment to the 2nd edition including general medical equipment updates. Corrigendum to the 2nd edition also added which is intended to help simplify interpretation and application of the General Standard.
2005 – Edition 3.0
The third revision to IEC 60601-1 happened in 2005. This edition focused more on risk management and adding means of patient protection (MOPP) and means of operator protection (MOOP). For certain equipment, requirements are supplemented or modified by special requirements of collateral or particular standard.
- 2006, 2007, 2008, 2009: Updates to address basic safety and performance of medical electrical equipment.
- 2012: Amendment 1 provides a tool to asses the significant changes between the third and second edition
- 2013, 2014: Updates to address basic safety and performance of medical electrical equipment