PD IEC/TR 60601-4-2:2016

What is PD IEC/TR 60601-4-2- Medical electrical equipment and systems performance about? 

PD IEC/TR 60601-4-2 is a safety standard on medical electrical equipment and medical electrical systems. 

PD IEC/TR 60601-4-2 applies to the performance of medical electrical equipment or a medical electrical system in the presence of electromagnetic disturbances. Hereafter, medical electrical equipment, or a medical electrical system are referred to as ME EQUIPMENT or an ME SYSTEM. 

The object of PD IEC/TR 60601-4-2 is to provide guidance on the assessment of the performance of ME EQUIPMENT or an ME SYSTEM in the presence of electromagnetic disturbances. 

Who is PD IEC/TR 60601-4-2- Medical electrical equipment and systems performance for?  

PD IEC/TR 60601-4-2 on guidance and interpretation for medical electrical equipment is relevant to: 

• Manufacturers of medical electrical equipment and medical electrical systems 
• Suppliers of medical electrical equipment and medical electrical systems 
• Testing authorities of medical EMC and performance testing 

Why should you use PD IEC/TR 60601-4-2-  Medical electrical equipment and systems performance? 

Medical electrical equipment and medical electrical systems are used in the practice of medicine because they provide needed functions that are associated with the intended use.  

PD IEC/TR 60601-4-2 provides guidance on assessing immunity, about the intended use. Based on the intended use, medical electrical equipment and medical electrical systems should have adequate immunity to provide the performance specified by the manufacturer in the presence of electromagnetic disturbances. 

Examples of performance that might not be basic safety or essential performance but that might be intended use include the following: 

• The ability to print an ultrasound image remotely 
• The ability of a scale to accurately measure patient weight 
• Accuracy of x-ray tube voltage in X-ray equipment for radiography and radioscopy, e.g., the error is less than 5 % 

In PD IEC/TR 60601-4-2, immunity test levels for performance are based on typical levels of EM disturbances. The purpose of PD IEC/TR 60601-4-2 is to provide a consistent method for evaluating the ability of medical electrical equipment or a medical electrical system to perform without degradation of performance in the presence of electromagnetic disturbances. The immunity test levels specified in PD IEC/TR 60601-4-2 are typical for the locations of intended use of medical electrical equipment and medical electrical systems. 

Overall, PD IEC/TR 60601-4-2 is useful as it provides guidance and examples to aid in the determination of specific, detailed immunity performance criteria. PD IEC/TR 60601-4-2 helps in identifying the specific hardware, firmware, and software functions that need to be verified during immunity tests.