When discussing the safety and performance of electrical medical devices, one standard stands above the rest: IEC 60601-1. This international document of over 400 pages serves as the foundation for nearly everything related to the design and approval of electrical medical devices. It defines the requirements for basic safety and essential performance, which, together with risk analysis, establish a widely accepted baseline for patient safety in medical devices. Let’s look at some important details this standard entails with Innokas Chief of Mechanical and Environmental Safety Lassi Oikarinen.

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Supporting standards – collateral and particular 

IEC 60601-1 doesn’t operate in isolation. It is accompanied by two supporting standards:  

• Collateral standards address aspects such as usability, alarm systems, and electromagnetic disturbance requirements and tests.  

• Particular standards tailored for specific devices, such as automated non-invasive sphygmomanometers (Blood pressure measuring devices), clinical thermometers, pulse oximeter equipment or multifunction patient monitoring equipment. 

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These standards complement – and sometimes override – the requirements of the main standard. 

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Early integration in product development 

Application of the standard begins early in product development, when a standards list is compiled for the device. This list defines which standards and versions will be applied. This phase is critical, as the international IEC standard has an EN version for Europe, along with several national versions, each with their own deviations from the international version. 

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Structure of IEC 60601-1 

The structure of IEC 60601-1 is extensive and multi-layered.  

• Sections 1–6 cover general requirements, such as device definitions, risk analysis, and type testing.  

• Sections 7–15 and 17 focus on ME EQUIPMENT (medical electrical equipment)  

• Section 16 addresses ME SYSTEMS (systems of medical electrical equipment). 

The standard also includes numerous annexes and sub-clauses, which provide background and clarification for the requirements. Often, the meaning of the standard’s text becomes clear only through these sub-clauses. 

Defining essential performance (EP) 

Essential performance (EP) is not directly defined in the main standard. It is the manufacturer’s responsibility to define EP through risk analysis, focusing on the solution’s clinical functions unrelated to basic safety. 

If the absence or degradation of a clinical function leads to unacceptable patient risk, it is considered part of the device’s EP. These EP definitions are often specified in device-specific particular standards. The device’s EP definition – or its absence – must both be clarified so that an accredited laboratory can execute standard compliancy verification according to IEC 60601-1. 

More than a technical document 

IEC 60601-1 is a cornerstone of patient safety and high-quality product development, not just a technical document. Understanding and applying it correctly are essential steps on the path to an approved and safe medical device. If you have any questions relating to this standard and its application to your solution, please do not hesitate to contact us through the link below.