Ensuring Quality & Performance in Wearable Medical Technology: Innovative Non-Destructive Testing Methods for IP67 Products

In modern healthcare, wearable technology has emerged as a revolutionary force, ushering in a new era of personalized and proactive health management. With such technology, healthcare providers are able to monitor and collect data while the patient is out in the world enjoying their lives. However, the intricate design and capabilities of these devices present a formidable challenge: sufficiently occluding liquid and dust to meet the stringent IP67 certification standards, all without destroying the product.

Overcoming this obstacle is paramount to safeguarding product integrity. Whether going for a bike ride or a hike in the rain, patients should not have to fret about damaging their devices. Thanks to advancements in non-destructive testing methods, overcoming this challenge has become more feasible than ever. This means manufacturers can now offer patients wearables that are both water-resistant and durable, providing peace of mind and reliability.

Wearable Medical Devices for Health, Nutrition, and Athletic Performance

Wearable devices have seamlessly integrated into society by adopting established and convenient designs. These commercially available gadgets, including smartwatches, rings, and pendants, enable health-conscious individuals to monitor various biometrics. In addition to wearables marketed for health enthusiasts, there are medical wearables engineered to meet the specific demands and critical monitoring needs of healthcare professionals, patients, and high-performance athletes. For example, continuous glucose monitors record the glucose concentrations of individuals with diabetes, insulin delivery systems can automatically administer medication, and photoacoustic patches can image hemoglobin. The high standards of IP67 give users confidence in these kinds of life-saving technologies, allowing them to enjoy day-to-day activities with peace of mind.

Understanding IP67: The Standard for Dust and Liquid Protection

Throughout a wearable’s lifespan, it must occlude liquids and dust, withstanding various usage environments and cleaning processes. In the case of medical wearables, the inclusion of dust or liquid into the device may compromise functionality and pose serious risks to the wearer. Due to these serious risks, the International Electrotechnical Commission (IEC) regulates the manufacturing of wearable technology and provides stringent requirements for product performance, including ingress protection against liquids and dust.

The IEC, under the international standard IEC 60529, describes the Ingress Protection (IP) code for how well a device is protected against water and dust. A device rated as IP67 is considered dust-tight and submersible in one meter of water for a limited time. For this reason, IP67 is a common standard for electronic devices, including wearables like smartwatches.

To meet the IP67 standard, manufacturers of wearables must design and test their products to prevent or detect micron-sized holes in seals, welds, or joints. This challenge is compounded by the need to conform to strict regulatory standards for medical devices, which limits the ability to conduct testing on the production line due to the destructive nature of the test requirements. While it is typically advised to use automated, non-destructive leak tests, selecting the appropriate testing approach relies on a range of factors. These include part attributes, leakage pathways, and the likelihood of failure. Once these factors have been identified, manufacturers frequently use non-destructive leak tests like pressure decay, differential pressure decay, or tracer gas sniffer/accumulation for ingress testing.

The Challenges of Leak Testing Wearable Devices

To ensure that electronic devices meet their claimed IP ratings, manufacturers must verify the integrity of device seals through standardized testing procedures. However, the complex nature of wearable devices raises several challenges for traditional testing, including:

1. Restrictive testing area: Due to the compact design of wearables, there is limited internal space for detecting pressure changes. Thus, to ensure measurement accuracy, it is crucial to minimize the volume of test circuits and fixtures.
   
   
2. No ports to fill from inside: Wearables often lack an internal filling port, which makes it impossible to test them using the standard pressure decay method. This necessitates specialized knowledge in leak testing and the development of tailored testing applications.
   
   
3. Accommodating flexible materials and complex geometries: Testing methods designed for rigid structures with conventional shapes may struggle with the elastic materials and irregular geometries of wearables. This may require porous restrictive areas limiting the movement of this flexible area while testing the product.

As the field of wearable technology develops and demand increases, manufacturers will require effective and reliable testing processes to address these obstacles and meet specification requirements and production goals.

Solving the Complexities of IP67 Testing Requirements with an Innovative Solution: The Sprint mD and the Sealed Component Leak Test

Challenges posed by non-destructive IP67 testing for medical wearables underscore the critical importance of robust solutions in ensuring product integrity and user safety. As wearable technology plays a pivotal role in healthcare, adherence to stringent standards, particularly IP ratings, becomes imperative.

The Sprint mD, a multi-channel leak and flow instrument, equipped with sealed component functionality. This innovative technology marks a significant advancement in efficiency, compliance, and excellence for wearable testing. It effectively overcomes the constraints of traditional water test methods, aligning with IP67 certification standards for enhanced reliability and performance.

 Advantages of the Sprint mD and Sealed Component Leak Test

The Sprint mD, with sealed component leak test functionality, offers a multitude of benefits for testing wearable devices:

• Rapid and Non-Destructive Testing: Using compressed air instead of water is non-destructive and accelerates cycle times.
• Customized Sealed Component Test Method: The proprietary sealed component test method, integrated into the Sprint mD, allows for customizing the reference volume based on the amount of headspace.
• Effectiveness Without Internal Filling Ports: The sealed component leak test ensures a comprehensive assessment of sealing integrity without relying on internal filling ports.
• Heightened Sensitivity for Small Parts: With minimal internal circuit volume, the Sprint mD exhibits heightened sensitivity, enabling the detection and measurement of gross leaks in small wearable parts with improved accuracy.
• Operational Excellence and Compliance: The Sprint mD delivers improved process insights through embedded fieldbus technology and advanced security features. This ensures compliance with regulatory requirements.

By utilizing the Sprint mD during the manufacturing process, manufacturers can confidently assess and guarantee the quality and reliability of their products against the risk of potential leaks in wearable technology. This not only streamlines the manufacturing process but also minimizes the likelihood of costly recalls or warranty claims associated with faulty seals or inadequate protection against environmental elements.  

Guiding the Future for Reliable Medical Wearable Testing

Advancements in wearable medical technology have opened new avenues for personalized health management. Ensuring the integrity and performance of these devices, particularly in meeting stringent IP67 certification standards, presents several key challenges.

Through the application of non-destructive testing methods, such as the Sprint mD with sealed component functionality, manufacturers can overcome these challenges and deliver high-quality, reliable wearable devices. This innovative solution allows for rapid and non-destructive testing, customized sealed component test methods, and heightened sensitivity for small parts. By utilizing such advanced testing technologies, manufacturers can streamline their production processes, ensure compliance with regulatory requirements, and provide users with confidence in the durability and reliability of wearable medical technology.

For more information on the Sprint mD click below.

If you need immediate assistance with an application or project, don’t hesitate to reach out to our team.  Click here to email us or call us at +1-281-671-2000. Let us know how we can help.