IEC 60601-1 is the primary standard governing the design of medical devices. While not all countries have adopted IEC 60601-1 as the standard, globally it has become the de facto international benchmark for the design of electronic medical devices.
IEC 60601-1 is a standard intended to be applied to all electro-medical devices traded internationally as a requirement for bringing new medical devices to market. 60601 was first published in 1977 and has been revised many times. The most recent revision, 60601 3rd edition was published in 2005. It was adopted in 2006 by the European Union impacting international medical device manufacturers. In January, 2014, the U.S. started enforcement of the 3rd edition of IEC 60601 for new medical devices (medical devices already on the market on this date were excluded from this enforcement).
There has been a great deal of focus on the standards set by IEC 60601. What are the particulars involved in this set of standards and why is it so important for healthcare administrators to purchase products that adhere to them? Let’s take a deeper look at the details surrounding IEC 60601 and the impact that it has on the healthcare industry.
Designing in Safety: Medical Electronic Manufacturers and IEC 60601
Designing an electronic device that can be used within the clinical setting and meets the standards set out in IEC 60601 is a long process. One of the biggest challenges that manufacturers face when it comes to developing electronic devices is making sure that the instruments in question sufficiently address issues of safety. The IEC 60601 standard was created to directly address these issues. The IEC 60601 standard addresses the risks associated with the use of electrical medical equipment. Purchasing a device that complies with the 60601 standard ensures that the device has gone through a complex series of testing before it is certified ready to bring to market.
Devices Covered by the IEC 60601
There are a varied number of devices that fall under the purview of the IEC 60601 standard. Devices that are used to diagnose, treat, or monitor patients and have one connection to an energy supply are covered by the standard. Should a device have physical contact either directly or indirectly with a patient and transfer energy such as electrical currents to or from the patient, then the device is covered by the regulations set by IEC 60601. Examples of products that are covered by this standard include infusion pumps, endoscopic cameras, MRI and gamma imaging systems, battery operated medical devices, accessories that may be associated with these devices, etc.
Evaluating Hazards Associated with the Use of Electronic Medical Devices
A primary focus that the IEC 60601 standard addresses is the exposure of both users and patients to hazards associated with electronic medical devices. A device that strictly complies with IEC 60601 ensures that hospital administrators, patients, and healthcare practitioners have reduced risks associated with the use of medical grade electronics. An example of this are the risks associated with the energy output of certain electronic medical devices. IEC 60601 directly addresses this issue through stringent rules on the design of medical devices so as to prevent any patient or operator from unintended exposure to electrical currents.
Non Conforming devices
Many hospitals & medical facilities have used traditional desktop computers, towers and all in ones produced by the big three throughout their operations ranging from operating rooms to patient registration and nursing stations. Such computers are not certified to IEC 60601 standards and present a potential risk to both the patient and healthcare practitioners that may cost hospitals millions in potential legal actions.
Manufacturers who create products that adhere to the IEC 60601 standard get to ensure that their devices meet product safety requirements from the initial design phase. This approach directly benefits patients & healthcare providers.