Medical electronics must meet extremely high standards for safety and reliability. A single error or breakdown might put a patient’s life at risk, so any piece of equipment must be exhaustively tested.
IEC 60601 is the primary guideline for how medical devices are designed and manufactured, ensuring that they are ready for the healthcare sector.
What is IEC 60601?
IEC 60601 is the international technical standard for electronic medical devices, as established by the International Electrotechnical Commission (IEC). The IEC was formed in 1906 to provide shared standards, guidelines, and language across national borders, and does so for virtually every industry that uses electronics.
While not the only technical standard that the IEC enforces, it is by far the most important for electronic medical devices.
Origins
IEC 60601 was originally published in 1977, a time when electrically powered medical devices were becoming increasingly common in the healthcare sector. Ventilators, imaging devices, and anesthesia machines all help providers deliver better results, but their electronic components had to be carefully regulated to prevent accidents from occurring. Thus, IEC 60601 was implemented.
Updates and Revisions
Over the years, IEC 60601 has undergone significant revisions and updates. In 1988 and 2005, the standard was completely republished to reflect the changing priorities in device safety, as well as the evolution of medical technology that had occurred.
Along with these significant changes, there are numerous amendments and updates to IEC 60601 that are meant to address ambiguities or questions that arise with new forms of technology. For example, the IEC published version 3.2 of IEC 60601-1, which updated risk management, usability, and software standards
What Does IEC 60601 Apply To?
IEC 60601 applies to any and all electronic devices designed specifically for healthcare environments, such as hospitals and clinics. It applies regardless of whether the device in question is meant for use by a healthcare provider or the general public.
Requirements and Structure
IEC 60601 consists of almost one hundred general, collateral, and particular standards governing electronic medical devices. Covering every single one is obviously outside the scope of this article, but we will focus on two of the most important standards that every medical-grade device must meet: IEC 60601-1 and IEC 60601-1-2.
- IEC 60601-1: This basic standard covers the safety of medical devices and their ability to stop electrical discharges from passing into a provider or patient using the device. A medical computer that meets this standard can be considered safe, reliable, and will not accidentally shock its user or patient while in use.
- IEC 60601-1-2: This standard governs the safety and effectiveness of electromagnetic compatibility and shielding of medical devices, ensuring that devices will not interfere with each other and are protected from outside disturbances.
Testing and Certification
Before submitting a medical device for testing, manufacturers must determine what parts of IEC 60601 are relevant to them. IEC 60601-1 and 60601-1-2 are standard for all devices, but further certifications will be required depending on the device’s intended role. For example, a device with radioactive emissions, such as an X-ray machine, must be tested under IEC 60601-1-3 standards.
Once their requirements are identified, manufacturers can begin integrating the necessary features into the product’s design. They must also conduct risk analysis and management plans, which identify potential dangers the device might face and how they will be managed. For example, a common risk for medical electronic devices is water damage. This risk can be managed by implementing a waterproof casing to protect the electrical components inside.
Testing is performed after initial prototyping is finished and all necessary measures have been integrated. While manufacturers can run pre-tests themselves, an official IEC 60601 test must be performed by an independent third party with ISO/IEC 17025 certification. This is to prevent falsified test results and ensure objectivity.
Benefits of IEC 60601
Given the challenges of implementing its requirements, what are the benefits of IEC 60601? A better way to frame it would be as a necessity. A device without IEC 60601 certifications is not worth using in the healthcare field.
Patient and Provider Safety
The first and most important factor that IEC 60601 ensures is the protection of healthcare providers and patients. Given that medical devices operate close to (or in some cases, inside) patients, it is extremely easy for any electrical discharge to jump from the device to the bodies of those nearby. An electrical short might also damage life-sustaining equipment such as a ventilator or pacemaker, putting that patient’s life in jeopardy. Designing and testing to IEC 60601-1 standards helps prevent this from happening.
Electromagnetic Harmony
Modern healthcare workflows rely on multiple devices working in concert with each other. A ventilator helps a patient breathe while a medical computer connected to monitoring equipment tracks the patient’s vital signs. If any one of these devices emits enough electromagnetic radiation to disrupt the others, it can have disastrous consequences. By meeting IEC 60601-1-2 standards, device manufacturers ensure that their products work harmoniously with other equipment.
Mark of Quality
For manufacturers, IEC compliance is an excellent way to showcase that their design and engineering teams are capable of delivering a quality product. An IEC 60601-compliant medical computer has been exhaustively tested and certified to work in real-world conditions just like those found in real hospitals and clinics. In turn, this gives end-users peace of mind, knowing that their equipment is proven and reliable.
IEC 60601-Certified Medical Computers from Cybernet
What is IEC 60601? It is the single most important certification that a medical tablet or computer can have. Without it, a device is not acceptable in healthcare. With it, you can rest assured that the device can protect you and your patients.
If you’re looking for IEC 60601-certified medical computers and tablets, contact the team at Cybernet Manufacturing. All of our medical-grade devices are extensively tested and certified before being shipped to our customers, ensuring a failure rate below 0.5%.