We validate the shelf life of medical devices through scientific methods—here's how we do it.

This year, the phrase that has captured our attention most is "novel coronavirus pneumonia." As a result, people have started paying extra attention to the healthcare industry—and among its critical concerns is the "shelf life of medical devices."

The shelf life of a medical device refers to the period during which the final product is guaranteed to perform as intended. Once this shelf life expires, the device may no longer meet its established performance standards or reliably deliver its intended function, potentially posing risks during use. To scientifically validate the shelf life of medical devices, the authoritative Third-party packaging inspection Institution, how do we carry out inspection and testing services?

1. What verification tests are typically conducted to ensure the shelf life of medical devices?

The types of validation tests for the shelf life of medical devices are divided into two categories: accelerated stability testing and real-time stability testing.

(1) Accelerated Stability Testing

An accelerated stability test involves placing a product under external stress conditions, examining how the material degrades over time under these stresses, and then using established acceleration factors and their relationship to degradation rates to predict the material's performance under normal storage conditions.

Required It should be noted that accelerated stability testing should not be used to verify the shelf life of medical devices if their raw materials or components are prone to degradation and damage under high-temperature conditions.

(2) Real-Time Stability Testing

Real-time stability testing involves placing a product under predefined storage conditions until its performance indicators no longer meet the specified requirements.

In real-time stability testing, appropriate conditions such as temperature, humidity, and light exposure should be determined based on the product's actual production, transportation, and storage scenarios. Products must be inspected at specified time intervals. Given that most regions in China have a subtropical climate, it is recommended to set the temperature and humidity conditions for validation tests as follows: 25°C ± 2°C and 60% RH ± 10% RH.

2. What are the various categories of testing, inspection, and evaluation items involved in verifying the shelf life of medical devices?

The testing items for the shelf-life validity of medical devices include two main aspects: product-specific performance testing and packaging system performance testing. The former requires selecting physical and chemical tests closely related to the device's shelf life, particularly for medical products where biocompatibility might change—these devices must undergo biological evaluation. If applicable, packaging seal integrity testing can be used as an alternative to sterility testing. As for the latter, it encompasses Medical Device Packaging Testing Testing items such as packaging integrity, packaging strength, and microbial barrier performance.

The center is Medical Device Packaging Testing We have extensive hands-on experience in performance testing of packaging systems in this area. As for Medical Device Packaging Testing The dye penetration method for testing seal integrity in breathable packaging, visual inspection, and the bubble test for detecting leaks in flexible packaging—all of these tests conducted as part of the package integrity assessment—can all provide professional insights. Medical Device Packaging Testing Services. Similarly, for the packaging strength testing items, this includes the sealing strength test for flexible barrier materials, the unconstrained packaging resistance-to-intrusion test, and Simulated transportation test, in Medical Device Packaging Testing The center is now equipped with advanced equipment and cutting-edge hard-shell technology, enabling it to meet a wide range of inspection and testing needs for our clients—thereby effectively ensuring the shelf life of medical devices.

III. What are the reference standards for validation testing of shelf life for medical devices?

(1) Basic Requirements and Quality System Standards

ISO 11607-1 "Packaging for Terminally Sterilized Medical Devices – Part 1: Materials, Sterile Barrier Systems, and Packaging System Requirements";

ISO 11607-2 "Requirements for Verification of Forming, Sealing, and Assembly Processes for Final Sterilization Medical Device Packaging – Part 2."

(II) Standard Methods for Testing Medical Device Packaging

1. YY/T 0681 Parts 1–5 of "Test Methods for Sterile Medical Device Packaging";

2. ASTM D 4169 "Performance Testing of Shipping Containers and Systems";

3. ASTM F 1608 "Test for Microbial Penetration Resistance Grade of Breathable Packaging Materials."

(III) Packaging Material Standards

YY/T 0698 Relevant content from Sections 2–10 of "Packaging Materials for Final Sterilized Medical Devices."