ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems is US Food and Drug Administration (FDA) approved standard for packaging performance test on medical device products. The standard simulates the various conditions that may be encountered in the actual transportation environment to evaluate the performance and reliability of the package. Packaging that complies with ASTM D4169 is basic requirement to ensure the integrity, safety, and tightness of medical device products during transportation.
ASTM D4169 provides the risks and safety hazards that medical device products may experience during transportation and establishes test methods at levels representative of those occurring in actual distribution, including loading, handling, stacking, impact, drop, vibration, environment, etc., during circulation. It is essential to ensure that the shipping packaging of medical device products can withstand the distribution process and reach the customer safe and undamaged.
Test Items including but not limited to
Test Items | Hazard Element |
Drop, impact,stability | Handling—manual andmechanical |
Compression | Warehouse Stacking |
Compression | Vehicle Stacking |
Vibration | Stacked Vibration |
Vibration | Vehicle Vibration |
Repetitive shock | Loose Load Vibration |
Longitudinal shock | Rail Switching |
Cyclic exposure | Environmental Hazard |
Vacuum | Low Pressure Hazard |
Impact | Concentrated Impact |
Intertek China, Hardline Products Testing Laboratory, with advanced testing equipment and ISTA trained technical team, has been certified by ISTA since 1989, with more than 30 years of experience in packaging and transportation testing services.
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About Intertek
Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.