Read and learn more about IEC 60601 and IEC 61010, and the factors you should consider when developing a regulatory-compliant medical device.
Electrical devices are part of our everyday lives, and they are undoubtedly cornerstones of our society and technology – this applies to the industries of life sciences and medical technology as well. However, it’s important to understand that these devices could also pose some risks, ranging from electrical shock, fire, and interference with other devices.
Due to their diverse and complex nature, medical devices can however be potentially prone to errors. In fact, a report found that from 2008 to 2017, 1.7 million injuries could probably have been related to medical devices. This further highlights the importance of meeting the regulatory standards for medical devices.
Fortunately, the regulatory world of medical electrical devices has been refined over several decades of robust standards as well as the newest, most advanced equipment. However, entering this segment without any prior experience can be a daunting task.
Understanding IEC 60601 and 61010: the two families of technical standards for medical devices
Generally, there are two main families of technical standards for medical electrical devices: IEC 60601 and IEC 61010.
The IEC 60601 family of standards is most commonly associated with medical electrical devices. This includes the safety and essential performance requirements for devices that have an applied part in contact with the patient; facilitate energy transfer to or from the patient; and devices that detect energy transfer to or from the patient.
Some of the devices that fall under this family of technical standards are ventilators, operating tables, x-ray machines, and hearing aids.
The IEC 61010 family of technical standards is for laboratory and measurement equipment, and applies to medical equipment outside the scope of IEC 60601. This includes laboratory equipment used for measurement and analysis – most commonly associated with in vitro medical devices, but also for industrial control devices. To help make the distinction between the two main families of technical standards, IEC 61010 is generally for medical devices that do not make any physical contact with the patients.
The two series of technical standards follow a similar structure: a general standard with a subset of standards applied, based on device type, environment, and application. For IEC 60601, this also includes a standard on electrostatic discharge (ESD).
Important factors to consider in developing your medical device
Given the complex nature of medical devices, keeping mentioned factors in mind while developing your medical device can assist you in the long run.
1. Consider the standards early on
Medical electrical equipment and devices are subject to more rigid and stringent requirements due to the nature of the field – a failure or an incident directly related to medical devices, will have major consequences. Therefore, it’s important to as early as possible, identify the main standard family, as well as the applicable subset of standards for the devices in question, to minimise and avoid issues during development.
2. Risk management is crucial
Risk management according to IEC 14971 is highly integrated in the IEC 60601 standard family. There are parts that provide requirements for the risk management file (RMF), as well as parts that require input from the RMF, e.g. risk based worst case scenarios to test. The same applies to usability according to IEC 62366.
While the IEC 61010 standard family is less integrated with the risk management and usability, both risk management and usability are still part of the requirements of the standard.
The risk management and usability management should be performed in parallel with development according to both standard families.
3. Identify the correct components for your medical device
With the abundance of electronic devices available today, there are plenty of choices when it comes to components for your medical device. It’s important to keep in mind that not all components suitable for everyday electronic and industrial devices, would be suitable for medical devices – this also applies to component ratings such as environment range, voltages, flammability classifications, and certification status.
Identifying exactly which components are crucial for the safety of your medical device is important, to ensure that the device will meet the certification for the intended market – something that will also help you prevent unexpected and avoidable issues during testing. It’s worth noting that opting for non-certified components at a lower price, can result in severe issues later that would end up costing you more.
4. Does your device have embedded software?
If so, there’s a chapter for programmable electrical medical systems (PEMS), which refers to the medical software standard IEC 62304. This may or may not be applicable based on whether the software is considered safety-critical or not. Since IEC 62304 is a process standard for software development, identification of applicable parts is important early on in order to be fully compliant.
Learn more about electrical safety standards of medical devices with Key2Compliance
Key2Compliance offers courses, conferences, and training tools that assist life sciences companies in meeting their goals. Besides this, we offer complete and optimised solutions for companies developing medical devices including diagnostics, fillers, and combination products.
If you’re interested in learning more about the electrical safety of medical devices, please watch our free 20 minute webinar with an introduction to IEC 60601.
