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- IEC 60601-1
IEC 60601-1 - Electrical Medical Equipment
TÜV Rheinland offers the IEC 60601-1 standard that addresses many of the risks associated with electrical medical equipment.
Electromedical products are defined under this standard as "equipment provided with no more than one connection to a particular supply mains and intended to diagnose, treat or monitor the patient under medical supervision and which makes physical or electrical contact with the patient and/or transfers energy to or from the patient and/or detects such energy transfer to or from the patient".
Examples of such products include battery-operated thermometers, MRI and gamma imaging systems, endoscopic cameras, infusion pumps, and similar. Accessories used with such equipment can also fall under this standard.
Impact of IEC 60601-1 third edition
Of course, as in any new edition of a standard fundamental change will accompany the transition from the second edition (1988) to the third edition (2005). In addition to making essential changes to the standard, third edition takes into account a broader range of products. As products and technology have evolved over the past 10 years so has third edition to include new technology and new approach to the basic principles of second edition.
One change to the edition that is driven by technology is the application and acceptance of IEC60950 (General Safety Requirements of Information and Technology Equipment) under certain circumstances.
Probably the most significant changes which will have the greatest impact on manufactures will be the requirement for a risk management process and the introduction of “Essential Performance”. Risk management shall be carried out in compliance with ISO 14971. This risk management also ties into demonstrating the device’s essential performance. Essential performance is described as characteristics of a device’s operation that can directly affect the safety of the patient, the user, or others.
