Bad puns aside, it’s good you’ve come to this post if you’re involved in developing or commercializing a new medical device, especially if that device has a battery or a plug.
In the world of medical device development, there are a number of international standards that apply. ISO standards 13485 and 14971, for example, spell out requirements for quality management systems and risk management processes, respectively. Though these documents can seem long, boring, and repetitive, they contain procedures to which a device company must adhere, beginning in the design phase and continuing throughout the product lifecycle.
A lesser-known, but still critically important, standard is IEC 60601 Medical Electrical Equipment. 60601 was developed to ensure the basic safety and essential performance of electrical equipment that comes into contact with patients during treatment or diagnosis.
As the medical device industry advances, it’s less and less common for new technologies to be purely mechanical in nature. Many medical products contain electrical components and range from very simple, such as a battery-operated thermometer, to extremely complex, such as an MRI machine. But, as disparate as these devices may be in their complexity and risk levels, both are governed by 60601 because they are used to “diagnose, treat, or monitor the patient under medical supervision” and they make “physical or electrical contact with the patient.” (This is a simplified version of the full definition found in the standard.)
What is IEC 60601-1? How do I know if it governs my device?
IEC 60601 is really a series of technical standards. 60601-1, known as the Collateral Standard, relates to all Medical Electrical (ME) equipment and ME systems (combination of ME and non-ME equipment items). Particular Standards also apply to specific types of ME equipment, such as 60601-2-2, which governs high frequency surgical equipment and accessories.
If your medical device product contains electrical components, it’s important to know the answers to a number of key questions, then find out what requirements come into effect. Here are some (not all) of the questions you should be asking:
- How is the device powered?
- What kind of environment will it be used in?
- Does it require sterilization? If so, how?
- Does the device emit radiation?
- Which parts of the device make contact with the patient? What kind of energy transfer occurs?
- Are there Particular Standards for this type of device?
The answers to these questions will determine which individual requirements apply. For instance, if your product will be used in a wet environment (such as an endoscope), that will impact the required construction of the housing and component selection. Hazards resulting from normal use or reasonably-foreseeable misuse must be guarded against. These will also impact the labeling requirements of your device.
Who checks if your device meets IEC 60601 requirements?
In the U.S., FDA’s Center for Devices and Radiological Health oversees the regulation of ME equipment and its adherence to 60601 and other applicable standards. Many other jurisdictions have adopted some form of the 60601 standards and inspect and enforce industry compliance through their respective regulatory agencies or notified bodies.
Where do I go for help with IEC 60601?
The good news is that not every medical product entrepreneur or clinical innovator needs to become an expert on IEC 60601. But it is essential that they understand that these and other technical standards exist and likely impact many of the decisions that will be made along their product’s path to market.
It’s also critical to understand that 60601 and other standards aren’t things to worry about only when it comes time for regulatory review of your product. These requirements have far-reaching implications near the beginning of and throughout the product development process, especially during the design phase. Materials selection, Cost-of-Goods, and many other factors critical to the commercial viability of your product are impacted.
If you need help understanding what technical requirements will apply to your device and how they may shape your path to market, contact Smithwise. Our team integrates technical standard requirements into every phase of the product development process, as well as consulting experts in specialty areas when they’re needed. We’ll be glad to talk with you about your project and the important considerations at each step along the way.