Medical Device Package Testing
Keystone Package Testing can provide all of the necessary testing a medical device would need. From an individual box to pallets, our equipment can meet the vibration, impact, temperature, and compression testing requirements. In addition to standard medical device transit testing, we also offer specialized testing as well. This includes sterile-barrier, shelf life, accelerated aging, seal strength, and other testing.
Summary of Package Testing For Medical Devices
In addition to the EMC testing that Medical Devices must undergo, they should also be tested for transportation safety. These medical devices are often expensive and fragile. It is imperative that they reach their destination safely. In many cases, the medical devices are sterile.
With tests designed specifically for sterilization and general transportation safety, Keystone can help ensure the medical devices reach their destination to provide the lifesaving purposes for which they were designed.
For medical devices, package validation testing is outlined in ISO 11607. The test consists of seal integrity (seal strength), material integrity (bubble leak), distribution testing, and package aging.
Why is Medical Device Package Testing Important?
From manufacturer to end-user hospital, doctor’s office, patient, etc.- a medical device will undergo stresses throughout the distribution process. Package testing will test the ability of a package to withstand the predictable stresses that it will encounter throughout distribution.
Product Integrity and Safety
Medical devices are sensitive and delicate products that require careful handling and protection during transportation. Proper testing ensures that the packaging adequately protects the devices from physical damage, temperature variations, humidity, and other environmental factors that could compromise their integrity and safety.
Compliance with Regulations
Regulatory authorities, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe, impose strict requirements for medical device packaging. Testing is essential to ensure compliance with these regulations, which are designed to safeguard patients and healthcare providers.
Transportation-related damages can lead to financial losses for manufacturers and distributors. Moreover, if a medical device’s packaging fails during transit, it could result in product recalls, delays in patient care, and potential harm to patients. Adequate testing helps identify potential weaknesses in the packaging design and allows for necessary adjustments before the devices reach the market.
Identifying and addressing packaging issues before mass production and distribution can save significant costs associated with potential recalls, replacements, or legal liabilities resulting from transportation-related damages.
Common Medical Device Package Testing Types
Like real-time aging, accelerated aging is used to demonstrate the integrity and sterility of packaged products stored over time. However, environmental conditions are expedited at a much faster rate.
For more information on accelerated aging testing, please visit the links below:
Bubble Leak / Dye Penetration
The purpose of dye penetration testing is to detect gross leaks in packaging.
Regarding sterilization of the medical device, one of the most common test standards is the ASTM F2096 also known as the Bubble Test. This test measures the material integrity of the package and is performed by submerging the package under water and increasing the internal pressure of the package.
Cold chain package testing is used to measure the effects of temperature and humidity on packages. ISTA 7D shipping tests can be used for the development of temperature-controlled transport packages made of any material. IEC 60601 applies to medical equipment in the home healthcare system
For more information on cold chain package testing, please follow the link below:
Seal strength testing evaluates the strength of seals in flexible barrier materials. This type of testing pertains to opening force and package integrity. Not only does seal integrity testing cover the strength of seals but it also evaluates the manufacturer’s packaging process, and their ability to produce consistent seals.
ASTM F88 measures the force required to separate a test strip of material containing the seal.
Expert Medical Device Testing Lab
Companies partner with us for package testing because of our high-quality work. We take pride in being a full-service testing laboratory that delivers accurate testing and reports in a timely fashion. Our customers appreciate the transparency and experience that we bring to every test.
The standards listed below are most commonly used for medical devices to ensure safety and sterilization throughout the distribution process. If you are looking for a specific test that you do not see on this list, please search our site for that standard or request a quote.
- ASTM D4169: Ship Testing
- ASTM F88: Seal Strength Testing
- ASTM F1140: Burst and Creep Testing
- ASTM F1929: Leak Testing
- ASTM F1980: Accelerated Aging Testing
- ASTM F2054: Burst Testing
- ASTM F2095: Leak Testing
- ASTM F2096: Leak Testing
- ASTM F3039: Leak and Dye Testing
- ISTA 7E: Temperature Testing
- ISTA 7D: Temperature Testing
- ISO 11607: Medical Device Testing