A comparison of the IEC 61010 and IEC 60601 standards series
As a prelude to our forthcoming IEC 61010 training courses, we take a look at the similarities and differences between the IEC 61010 and the IEC 60601 series of standards, and going further the reasons why in certain areas, particularly electromagnetic compatibility (EMC) the latter is preferred.
The IEC 61010 series of safety standards is applicable for the safety requirements for electrical equipment for measurement, control and laboratory use. In theory independent from the requirements for Medical Electrical (ME) Equipment governed by the IEC 60601, where the main focus of the IEC 60601 series is preventing harm to patients, either connected to the ME Equipment through an applied part, or where energy is transferred to the patient or measured from the patient. The focus of the IEC 61010 series is on electrical tests and measurement equipment, electrical process-control equipment and electrical laboratory equipment.
What sets the IEC 60601 series apart from the IEC 61010 series is the potential higher risk of electrocution through low impedance contact to a patient. IEC 60601 places a greater emphasis on risk analysis and includes a section on Programmable Electrical Medical Systems (PEMS), which is the first step towards assessing embedded systems and the functional safety thereof.
Although omitting certain clauses listed above, there are aspects of the IEC 61010 series that address key safety-related items in a more concise and informative manner. As covered in our blogs “Isolation distances are not so creepy!” and “Cleaning Up Your MOPPs”, the electrical safety challenges in IEC 60601 manifest themselves in two categories – Means of Operator Protection (MOOP) and Means of Patient Protection (MOPP). Due to the lack of an applied part in contact with a patient, IEC 61010 focuses on the former. Over the years of running our IEC 60601 training courses, one topic that crops up time and time again is electrical safety in section 8. Many people find the 65 page section and subsequent annexes confusing, which is not surprising as there is a huge amount of information packed into the section.