Medical devices undergo a thorough and highly regulated process for compliance to ensure safety and performance in their respective applications. These standards heavily influence how products are designed, engineered, and manufactured, long before they ever hit the market. Here’s how we approach this process at Kickr Design.
An Overview of Medical Device Standards
IEC 60601 is the primary series of standards established by the International Electrotechnical Commission (IEC) that defines the requirements for safety and performance that medical devices must adhere to. ISO 60601 also establishes standards for medical equipment and is often connected to IEC standards.
Devices That Need IEC 60601 Electrical Testing
Any product that is considered a class II device that contains any electronics and is proceeding through a 510(k) will go through some level of ISO 60601 testing. The ISO standard for each device is roughly 1,000 pages, though not all regulations apply to each device. We’ll first examine the product against the standard to determine exactly what applies and begin production and testing accordingly.
How We Perform Electrical Safety Tests Under IEC 60601
After determining initial feasibility, we’ll conduct Formative Testing to gain confidence in the design and identify any potential issues. We can perform these tests in-house or at a registered testing lab, but they are not used in the submission. This typically occurs in phase II before performing the official verification testing. This leaves room for opportunities to iterate in an earlier design phase, potentially avoiding major failures. Once these tests are performed, official testing can begin in alignment with pre-approved protocols.
Common Challenges Or Pitfalls
We’ve found that most product design and engineering firms don’t have enough time or adequate room in the budget to perform the extensive testing necessary. Medical device testing for compliance is costly and time-consuming. Most projects require multiple iterations and involve major and minor failure investigations.
Maintaining Up-To-Date Testing
The IEC 60601 is constantly evolving with new versions or amendments. This presents practical challenges to our design and engineering process, but our approach to Quality Assurance and compliance is always to be proactive. Our engineers and team members continuously stay informed about new versions of applicable standards for anything from FDA guidance on the use of AI in drug development and electrical grounding to interference and water ingress protection.
Knowing of possible changes in advance ultimately saves time and resources by negating the need to re-engineer products later. All of our 3rd-party contract test labs are also required to stay informed on the latest test protocols and standards, and are often an asset during the testing process.
If you have an idea for a medical device or want to improve one you use, we can help. Our engineering team will walk you through the process and help you make informed decisions at every turn. Reach out here and receive a free cost estimate.