Hermeticity Testing for Implanted Medical Devices

How we identify potentially hazardous defects in hermetically sealed medical implants

Lack of adequate testing of implanted medical devices can have serious consequences. Cardiac pacemakers, cardiac defibrillators, cochlear implants, neurostimulators and other implantable devices require thorough quality control testing to verify safety and reliability.

Hermetically sealing internal medical devices against moisture and body fluids is crucial to the dependability of implantable devices. Medical devices use a variety of materials (metals, ceramics and plastics) and joining processes. Each type of seal process can be measured and verified to meet required leak rate limits.

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Given the complexity of medical device implants and the number of variables, including design, materials and processes, medical device testing is imperative. ORS offers a wide range of advanced hermetic seal testing methods and instrumentation to detect the presence of moisture or leakage of outside air into medical implants. We want to ensure your implanted medical devices are protected from moisture and other gas contents that can cause the device to fail prematurely.

ORS’s accurate and reliable medical device testing is designed to uncover anomalies and avoid the need for recalls associated with untested or improperly tested devices. We provide peace of mind knowing that you’re working with industry experts and a world leader in package hermiticity and gas analysis testing. Whether you’re testing new products before market release, assessing current product performance or qualifying medical device shipments for conformance to a specification, you’ll be certain that entrapped water vapor, hydrogen or hermetic leaks won’t impact your development progress.

Internal Vapor Analysis

We use internal vapor analysis (IVA®) testing to determine the identities and quantities of gas within microelectronic components. This is also called residual gas analysis (RGA) testing or internal water vapor content (IWVC) testing. ORS’s engineers have refined the internal vapor analysis process, creating the industry’s most precise and reliable test methodology for hermetic seal integrity and internal moisture concentrations.

IVA® tests involve quantitatively measuring all primary and trace gases within hermetic components. IVA® testing focuses on seal quality control and control of outgassing from package piece parts and other materials, including adhesives and coatings used within the sealed enclosure.

ORS conforms to the highest standards when conducting IVA® testing. We can help whether you’re assessing current medical device performance, testing new products before market release or qualifying product shipments for conformance to a specification. With us, you’ll have absolute confidence that entrapped water vapor or hermetic leaks won’t impair your development progress, require costly replacements or negatively affect product performance.

In addition to standard IVA®, ORS offers high-resolution internal vapor analysis (HR-IVA®) testing, addressing the difficulties of measuring volatiles within increasingly smaller-volume (nanoliter) microelectronic packages.

Hermetic Package Testing

Ingress of moisture into hermetically sealed implanted medical devices can cause device errors or catastrophic failure. The crucial nature of this testing led ORS to perfect multiple primary hermetic test approaches to defend against moisture and contaminants that threaten a sealed system.

HSHLD® Testing: ORS’s high sensitivity helium leak detection (HSHLD®) method simultaneously measures helium and oxygen levels to determine fine and gross leaks. HSHLD® is a dry gross and fine method sensitive to 1 x 10-12 atm cc/sec, with cycle times of less than two minutes. This simplified, yet comprehensive test can measure leak rates of devices with internal free volumes as small as 0.001cc.
Krypton-85 Testing: This radioactive isotope method determines fine and gross leak rates in a high-reliability device, often used in critical medical devices, military components, commercial sensors and similar applications. The Krypton-85 method provides extremely fast test times, lower overall costs and testing in ambient conditions. It can also find thermally induced or pressure-induced hermetic failures.
Custom Leak Testing: ORS employs helium or other gases (Argon/Xenon/Oxygen/Krypton) to verify the fine leak seal integrity of any hermetic device. Custom leak test plans are available upon request.

Gas Chromatography and Mass Spectrometry

A natural complement to the IVA® test, gas chromatography/mass spectrometry (GC/MS) combines two techniques to identify unknown organic compounds detected during standard IVA® testing, plus compounds that may not have been detected by standard IVA®. ORS’s proprietary instrument design unites the separative features of gas chromatography with the identification capabilities of mass spectrometry, providing unprecedented speed and accuracy analyzing a variety of package or sample sizes and complexities.

GC/MS can be used to identify contamination, residual cleaning solvents, solder flux residue, epoxy curing problems, polymer degradation and additional breakdown byproducts with ppb-level sensitivity on devices with cavity sizes as small as <0.00001cc. Results can be used alone or combined with standard IVA® testing to determine if ongoing or propagated chemical reactions, corrosion or chemical deposition could affect long-term implanted medical device reliability. We also offer GC/MS testing for analytical applications focused on contamination identification, purity determination, outgassing studies, and identification of volatile and semi-volatile substances. Test results are qualitative for compound identification and semi-quantitative for concentration. They are customizable to your specific analysis needs.