In medical device development, situations arise where a new type of device has no existing particular standard. In such cases, designers and manufacturers must rely solely on the IEC 60601-1 main standard and a thorough risk analysis. This doesn’t mean the process becomes lighter; a device that falls under no particular standard demands careful definition and documentation. Let’s look into what this means in practice with expert guidance.

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Learn more about IEC 60601-1 as the central medical device standard

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Defining the device, its use and essential performance

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"The first step is to define the intended use and classification of the medical electrical equipment (ME Equipment) or medical electrical system (ME System). Is it portable, fixed, mobile, hand-held, or body-worn? Does it have patient contact? These factors directly influence which testing methods and requirements apply," says Innokas Chief of Mechanical and Environmental Safety Lassi Oikarinen.

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Without a particular standard, the manufacturer must define the device’s essential performance (EP) requirements. This is done through risk analysis, evaluating the device’s clinical functions and their impact on patient safety. If a function is critical to the treatment process, its absence or degradation may pose an unacceptable risk, making it part of the EP definition.

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Devices without essential performance

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Some medical devices may not have EP at all. For example, a low-risk (EU MDR Class I) device like a medical PC that is not intended to support clinical decision-making may not require an EP definition. In such cases, only basic safety requirements from IEC 60601-1 apply. A good example is protection against electric shock and structural safety.

Still, the device must meet single fault safety requirements identified in the risk analysis. This can be achieved through redundancy, such as duplicating safety mitigation measures. If the device has no patient contact, requirements like 2MOPP (Means of Patient Protection) do not apply.

"Interestingly, a Class I medical PC compliant with IEC 60601-1 Ed. 3.2 is easier to integrate into a broader ME SYSTEM than, for example, a consumer-grade PC compliant with IEC 62368-1 Ed. 4.0. This makes it a more suitable choice for medical environments," Lassi shares.

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Applying IEC 60601-1 without a particular standard

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IEC 60601-1 provides a comprehensive framework but applying it without a particular standard requires expertise and judgment. It is the manufacturer’s responsibility to demonstrate that the device meets safety requirements either through the standard or other acceptable means. This highlights the importance of risk analysis and documentation in product development.

"Developing a new device type without a particular standard is an opportunity to innovate, as long as safety and performance remain the top priorities," Lassi summarises.